The following data is part of a premarket notification filed by Sterile Concepts, Inc. with the FDA for Skin Staple Removal Trays.
| Device ID | K943046 |
| 510k Number | K943046 |
| Device Name: | SKIN STAPLE REMOVAL TRAYS |
| Classification | Suture Removal Kit |
| Applicant | STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Contact | Kay Andrews |
| Correspondent | Kay Andrews STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Product Code | MCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1994-07-29 |