The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Cordcap.
| Device ID | K091380 |
| 510k Number | K091380 |
| Device Name: | CORDCAP |
| Classification | Cord, Retraction |
| Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Contact | John Discko |
| Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-05-11 |
| Decision Date | 2009-07-30 |
| Summary: | summary |