Ace Custom Surgical Pack
by Ace Surgical Supply Co., Inc.
510(k) K922648
Ace Custom Surgical Pack is a Class II device made by Ace Surgical Supply Co., Inc., cleared under FDA 510(k) K922648 on 20 Mar 1993, 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)SESK | NumberK922648 | Date20 Mar 1993 | StatusActive |
Official records
- FDA 510(k) database K922648
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- Withdrawn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
- SESK Substantially Equivalent — Kit
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