ProSeal Injection Site Extended Male Luer Lock (422140)
Epic Medical Pte. , Ltd. · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Singapore
- Advisory committee description
- General Hospital
- Address 1
- 105 Cecil St. #20-04, The Octagon, Singapore 069534
- Statement or summary
- Summary
- Product code
- ONB
- Zip code
- 069534
- Applicant
- Epic Medical Pte. , Ltd.
- Decision date
- 2024-05-21
- Decision code
- SESE
- Country code
- SG
- Device name
- ProSeal Injection Site Extended Male Luer Lock (422140)
- Advisory committee
- HO
- Contact
- Freddie Lee
- K number
- K240433
- Date received
- 2024-02-14
- Review advisory committee
- HO
- Postal code
- 069534
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Medical specialty description
- General Hospital
- Regulation number
- 880.5440
- Device class
- 2
- Registration number
- 3045891669, 3013055489, 3012798826, 3010882708, 3018681450, 2025816, 9617594, 3030447506, 3008717264, 3012410077, 3030733800, 3030384100, 3012039263, 2183828, 2183744, 2024024, 3003152976, 3030626857, 3008729892, 3002808227, 2032112, 3012429465, 3015462350, 2032098, 3008349578, 1710034, 3043226252, 3007829657, 3012494290, 3009631669, 3013764800, 3002682307, 3013557562, 3013319212, 1423507, 3008468447, 3008434487, 9616066, 2243072, 3010423292 +2 more
- FEI number
- 3045891669, 3013055489, 3012798826, 3010882708, 3018681450, 3002808169, 2025816, 3030447506, 3008717264, 3012410077, 3030733800, 3030384100, 3012039263, 2183828, 2183744, 2024024, 3003152976, 3030626857, 3002808227, 3012429465, 3015462350, 3008349578, 1710034, 3003058448, 3043226252, 3007829657, 3002807615, 3012494290, 3009631669, 3013764800, 3002682307, 3013557562, 3013319212, 3008002452, 3008468447, 3008434487, 3002807555, 2243072, 3010423292, 3003076831 +2 more