The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Dexon Rapid (dexon R).
| Device ID | K980610 |
| 510k Number | K980610 |
| Device Name: | DEXON RAPID (DEXON R) |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-05-18 |
| Summary: | summary |