The following data is part of a premarket notification filed by Medicine Lodge, Inc. with the FDA for Expanded Body Suture.
| Device ID | K961025 |
| 510k Number | K961025 |
| Device Name: | EXPANDED BODY SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MEDICINE LODGE, INC. 819 STRIKER AVE., SUITE 10 Sacramento, CA 95834 -5432 |
| Contact | Brian T Cleary |
| Correspondent | Brian T Cleary MEDICINE LODGE, INC. 819 STRIKER AVE., SUITE 10 Sacramento, CA 95834 -5432 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-14 |
| Decision Date | 1996-04-15 |
| Summary: | summary |