INGLAT-O-BALL

Pessary, Vaginal

MILEX PRODUCTS, INC.

The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Inglat-o-ball.

Pre-market Notification Details

• Device ID: K904774
• 510k Number: K904774
• Device Name: INGLAT-O-BALL
• Classification: Pessary, Vaginal
• Applicant: MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631
• Contact: Gary Chuven
• Correspondent: Gary Chuven; MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631
• Product Code: HHW
• CFR Regulation Number: 884.3575 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-22
• Decision Date: 1990-12-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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