SEMINOR

Cannula, Intrauterine Insemination

PROMEDEX, INC.

The following data is part of a premarket notification filed by Promedex, Inc. with the FDA for Seminor.

Pre-market Notification Details

• Device ID: K905764
• 510k Number: K905764
• Device Name: SEMINOR
• Classification: Cannula, Intrauterine Insemination
• Applicant: PROMEDEX, INC. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162
• Contact: Richard A Hamer
• Correspondent: Richard A Hamer; PROMEDEX, INC. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162
• Product Code: MFD
• CFR Regulation Number: 884.5250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-12-27
• Decision Date: 1991-03-12