The following data is part of a premarket notification filed by R.k. Medical, L.l.c. with the FDA for Plain Gut & Chronic Gut Absorbable Surgical Sutures Usp.
| Device ID | K961931 |
| 510k Number | K961931 |
| Device Name: | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP |
| Classification | Suture, Absorbable, Natural |
| Applicant | R.K. MEDICAL, L.L.C. ONE LETHBRIDGE PLAZA SUITE 4 Mahwah, NJ 07430 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly R.K. MEDICAL, L.L.C. ONE LETHBRIDGE PLAZA SUITE 4 Mahwah, NJ 07430 |
| Product Code | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-07-29 |
| Summary: | summary |