The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Modification To Endotine Ribbon.
| Device ID | K060828 |
| 510k Number | K060828 |
| Device Name: | MODIFICATION TO 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 | 2006-03-27 |
| Decision Date | 2006-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399006820 | K060828 | 000 |