The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Iso-elastic Cerclage System.
| Device ID | K030256 |
| 510k Number | K030256 |
| Device Name: | ISO-ELASTIC CERCLAGE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
| Contact | Vineet Sarin |
| Correspondent | Vineet Sarin KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-24 |
| Decision Date | 2003-10-21 |