MONOFIX PDO
Samyang Holdings Corporation · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Daedeok-Gu
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 55, Munpyeongseo-Ro 18beon-Gil
- Statement or summary
- Summary
- Product code
- NEW
- Zip code
- 34302
- Applicant
- Samyang Holdings Corporation
- Decision date
- 2026-08-25
- Decision code
- SESE
- Country code
- KR
- Device name
- MONOFIX PDO
- Advisory committee
- SU
- Contact
- Kim Ahram
- K number
- K253879
- Date received
- 2025-12-04
- Review advisory committee
- SU
- Postal code
- 34302
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Suture, Surgical, Absorbable, Polydioxanone
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4840
- Device class
- 2
- Registration number
- 1614993, 3010864832, 1221934, 3006680097, 2648650, 3007205024, 3010041511, 3010462274, 3015289316, 3030733800, 3004365956, 3016560306, 1064584, 3010692967, 3014615644, 3043226252, 3005953126, 3003828812, 2210968, 3013376016, 3007791599, 3006981798, 3006638824, 3011137372, 3014272734, 9617547, 3038138322, 3012494290, 2246552, 1221601, 3020983460, 3014579161, 3006562124, 3007895168, 3008912461, 3027329031, 3014461810, 1055236, 2125050, 3016244792 +47 more
- FEI number
- 1614993, 1221934, 3006680097, 2648650, 3007205024, 3010862763, 3010041511, 3010462274, 3015289316, 3030733800, 3004365956, 3016560306, 1000112877, 3010692967, 3014615644, 3043226252, 3005953126, 3003828812, 2210968, 3013376016, 3007791599, 3006981798, 3006638824, 3014272734, 3038138322, 3012494290, 2246552, 1221601, 3020983460, 3014579161, 3006562124, 3007895168, 3008912461, 3027329031, 3014461810, 2125050, 3016244792, 3004117249, 3005972890, 3016904853 +47 more