MAXX

Condom

MAYER LABORATORIES

The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Maxx.

Pre-market Notification Details

• Device ID: K946376
• 510k Number: K946376
• Device Name: MAXX
• Classification: Condom
• Applicant: MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607
• Contact: Dabid Mayer
• Correspondent: Dabid Mayer; MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-14
• Decision Date: 1995-09-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850002174335	K946376	000
00850002174328	K946376	000