SELECT IUI

Cannula, Intrauterine Insemination

SELECT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Select Medical Systems, Inc. with the FDA for Select Iui.

Pre-market Notification Details

• Device ID: K954099
• 510k Number: K954099
• Device Name: SELECT IUI
• Classification: Cannula, Intrauterine Insemination
• Applicant: SELECT MEDICAL SYSTEMS, INC. 2 WINTERSPORT LN. Williston, VT 05495
• Contact: Monique Girard
• Correspondent: Monique Girard; SELECT MEDICAL SYSTEMS, INC. 2 WINTERSPORT LN. Williston, VT 05495
• Product Code: MFD
• CFR Regulation Number: 884.5250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-31
• Decision Date: 1995-11-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20888937003653	K954099	000
20888937003592	K954099	000