THE KEEPER

Cup, Menstrual

THE KEEPER CO.

The following data is part of a premarket notification filed by The Keeper Co. with the FDA for The Keeper.

Pre-market Notification Details

• Device ID: K870803
• 510k Number: K870803
• Device Name: THE KEEPER
• Classification: Cup, Menstrual
• Applicant: THE KEEPER CO. P.O. BOX 20023 Cincinnati, OH 45220
• Contact: Lou Crawford
• Correspondent: Lou Crawford; THE KEEPER CO. P.O. BOX 20023 Cincinnati, OH 45220
• Product Code: HHE
• CFR Regulation Number: 884.5400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-02-27
• Decision Date: 1987-05-06