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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 K896098
Device Name GUARDIAN & JANITEX CONDOM/PROPHYLACTIC
Applicant
Allied Rubber Industries Sdn. Bhd.
2009, Kawasan Miel
Lot 2, Jalan Beremban 15/12,
400000 Shah Alam.Malaysia,  MY
Applicant Contact TONG
Correspondent
Allied Rubber Industries Sdn. Bhd.
2009, Kawasan Miel
Lot 2, Jalan Beremban 15/12,
400000 Shah Alam.Malaysia,  MY
Correspondent Contact TONG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/20/1989
Decision Date 12/19/1990
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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