INSEMI-CATH

Cannula, Intrauterine Insemination

COOK OB/GYN

The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Insemi-cath.

Pre-market Notification Details

• Device ID: K931630
• 510k Number: K931630
• Device Name: INSEMI-CATH
• Classification: Cannula, Intrauterine Insemination
• Applicant: COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460
• Contact: Tammy Bacon
• Correspondent: Tammy Bacon; COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460
• Product Code: MFD
• CFR Regulation Number: 884.5250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-04-02
• Decision Date: 1994-04-19