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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 K871036
Device Name CONDOM TAKASO RUBBER PRODUCTS SDN/BDH
Applicant
Takaso Rubber C/O Interstate Supplier, Inc.
7135 Hollywood Blvd. #509
Los Angeles,  CA  90046
Applicant Contact DOUGLAS LIN
Correspondent
Takaso Rubber C/O Interstate Supplier, Inc.
7135 Hollywood Blvd. #509
Los Angeles,  CA  90046
Correspondent Contact DOUGLAS LIN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/17/1987
Decision Date 10/20/1987
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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