The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Silk Suture.
| Device ID | K982853 |
| 510k Number | K982853 |
| Device Name: | SILK SUTURE |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Contact | Vanada Johnson |
| Correspondent | Vanada Johnson DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-13 |
| Decision Date | 1999-04-30 |
| Summary: | summary |