The following data is part of a premarket notification filed by Sterile Concepts, Inc. with the FDA for Suture Removal Trays.
| Device ID | K943090 |
| 510k Number | K943090 |
| Device Name: | SUTURE REMOVAL TRAYS |
| Classification | Wrap, Sterilization |
| Applicant | STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves STERILE CONCEPTS, INC. 5100 COMMERCE RD.. Richmond, VA 23234 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1994-08-22 |