The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Gift Catheter Set/s.
Device ID | K983590 |
510k Number | K983590 |
Device Name: | GIFT CATHETER SET/S |
Classification | Catheter, Assisted Reproduction |
Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Contact | Brenda Davis |
Correspondent | Brenda Davis COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Product Code | MQF |
CFR Regulation Number | 884.6110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-13 |
Decision Date | 1998-12-21 |
Summary: | summary |