The following data is part of a premarket notification filed by Cooper Surgical with the FDA for Coopersurgical Malleable Sytlet.
| Device ID | K023382 |
| 510k Number | K023382 |
| Device Name: | COOPERSURGICAL MALLEABLE SYTLET |
| Classification | Catheter, Assisted Reproduction |
| Applicant | COOPER SURGICAL P.O. BOX 2156 Huntington, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary COOPER SURGICAL P.O. BOX 2156 Huntington, CT 06484 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2002-12-20 |
| Summary: | summary |