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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K150828
Device Name O-RING Condom
Applicant
O-Ring Products, LLC
4012 Grand Manor Court #208
Raleigh,  NC  27612
Applicant Contact William Mistler
Correspondent
O-Ring Products, LLC
4012 Grand Manor Court #208
Raleigh,  NC  27612
Correspondent Contact William Mistler
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/30/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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