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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 K090259
Device Name OKAMOTO ULTRA THIN
Applicant
OKAMOTO U.S.A., INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
washington,  DC  20005
Applicant Contact jeffery n gibbs
Correspondent
OKAMOTO U.S.A., INC.
700 THIRTEENTH STREET, N.W.
SUITE 1200
washington,  DC  20005
Correspondent Contact jeffery n gibbs
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/02/2009
Decision Date 03/31/2009
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
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