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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 K942858
Device Name LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
Applicant
SURETEX, LTD.
71 SOI SAP, SIPRAYA,
BANGKOK 10500,
THAILAND,  TH 10500
Applicant Contact ASHOK MUKHERJEE
Correspondent
SURETEX, LTD.
71 SOI SAP, SIPRAYA,
BANGKOK 10500,
THAILAND,  TH 10500
Correspondent Contact ASHOK MUKHERJEE
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/16/1994
Decision Date 05/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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