The following data is part of a premarket notification filed by Trading Consultants And Distributors Intl., Inc. with the FDA for Polypropylene.
| Device ID | K993997 |
| 510k Number | K993997 |
| Device Name: | POLYPROPYLENE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-02-04 |
| Summary: | summary |