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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 K952393
Device Name OKAMOTO CONDOM
Applicant
Okamoto USA, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact JEFFERY N GIBBS
Correspondent
Okamoto USA, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact JEFFERY N GIBBS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/22/1995
Decision Date 08/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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