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 |