The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Synthetic Absorbable Suture.
| Device ID | K944937 |
| 510k Number | K944937 |
| Device Name: | SYNTHETIC ABSORBABLE SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Sally L Maher |
| Correspondent | Sally L Maher JOHNSON & JOHNSON INTERNATIONAL 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-06 |
| Decision Date | 1995-05-19 |