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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 K980019
Device Name HTL MALE CONDOM
Applicant
REDDY MEDTECH HEALTH PRODUCTS LTD.
S-59, 20TH ST.
ANNANAGAR WEST
chennai,  IN 600 040
Applicant Contact a.v.k. reddy
Correspondent
REDDY MEDTECH HEALTH PRODUCTS LTD.
S-59, 20TH ST.
ANNANAGAR WEST
chennai,  IN 600 040
Correspondent Contact a.v.k. reddy
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/02/1998
Decision Date 04/01/1998
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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