The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Capsew Plication System.
| Device ID | K071796 |
| 510k Number | K071796 |
| Device Name: | CAPSEW PLICATION SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette |
| Correspondent | David J Collette CAYENNE MEDICAL, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-10-19 |
| Summary: | summary |