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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 K980964
Device Name MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
Applicant
LS RUBBER SDN BHD
2443 FILLMORE ST.
SUITE 135
SAN FRANCISCO,  CA  91115
Applicant Contact MOHAMAD FIRDAOS BIN MOHAMED
Correspondent
LS RUBBER SDN BHD
2443 FILLMORE ST.
SUITE 135
SAN FRANCISCO,  CA  91115
Correspondent Contact MOHAMAD FIRDAOS BIN MOHAMED
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/16/1998
Decision Date 03/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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