Wound Closure Kit
by Megadyne Medical Products, Inc.
510(k) K910365
Wound Closure Kit is a Class II device made by Megadyne Medical Products, Inc., cleared under FDA 510(k) K910365 on 28 Mar 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910365 | Date28 Mar 1991 | StatusActive |
Official records
- FDA 510(k) database K910365
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LRO
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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