The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Novy Cornual Cannulation Set.
Device ID | K931476 |
510k Number | K931476 |
Device Name: | NOVY CORNUAL CANNULATION SET |
Classification | Catheters, Salpingography |
Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Contact | Dexter Elkins |
Correspondent | Dexter Elkins COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Product Code | MOV |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-24 |
Decision Date | 1995-07-28 |