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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K252158
Device Name Sagami Original 002 Polyurethane Male Condom
Applicant
Mayer Laboratories
1400 Shattuck Ave. Suite 9
Berkeley,  CA  94709
Applicant Contact David Mayer
Correspondent
Mayer Laboratories
1400 Shattuck Ave. Suite 9
Berkeley,  CA  94709
Correspondent Contact David Mayer
Regulation Number884.5300
Classification Product Code
MOL  
Date Received07/09/2025
Decision Date 03/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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