The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Lukens 2-0 Braided Silk Sutures.
| Device ID | K922254 |
| 510k Number | K922254 |
| Device Name: | LUKENS 2-0 BRAIDED SILK SUTURES |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Greg W Shipp |
| Correspondent | Greg W Shipp QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1992-09-01 |