The following data is part of a premarket notification filed by Trading Consultants And Distributors Intl., Inc. with the FDA for Polyglycolic Acid.
| Device ID | K994001 |
| 510k Number | K994001 |
| Device Name: | POLYGLYCOLIC ACID |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. 157 WINDDANCE DR. Chicago, IL 60046 |
| Contact | Main M Ghazal |
| Correspondent | Main M Ghazal TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. 157 WINDDANCE DR. Chicago, IL 60046 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-02-09 |
| Summary: | summary |