The following data is part of a premarket notification filed by Cooper Surgical with the FDA for Coopersurgical Trial Transfer Catheter.
Device ID | K023384 |
510k Number | K023384 |
Device Name: | COOPERSURGICAL TRIAL TRANSFER CATHETER |
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 | 2002-12-13 |
Summary: | summary |