The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Suture Removal Kit.
| Device ID | K855131 |
| 510k Number | K855131 |
| Device Name: | SUTURE REMOVAL KIT |
| Classification | Scissors, Medical, Disposable |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | Marvin D Schattner |
| Correspondent | Marvin D Schattner DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | JOK |
| CFR Regulation Number | 880.6820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-01-13 |