The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Endotine Ribbon.
| Device ID | K050611 |
| 510k Number | K050611 |
| Device Name: | ENDOTINE RIBBON |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94303 |
| Contact | Linda Ruedy |
| Correspondent | Linda Ruedy COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto, CA 94303 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-09 |
| Decision Date | 2005-04-06 |
| Summary: | summary |