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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 K992081
Device Name VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
Applicant
SURETEX PROPHYLACTICS (INDIA) LTD.
1500 INDUSTRIAL RD.
P.O. BOX 1252
dothan,  AL  36302
Applicant Contact lon d mcilvain
Correspondent
SURETEX PROPHYLACTICS (INDIA) LTD.
1500 INDUSTRIAL RD.
P.O. BOX 1252
dothan,  AL  36302
Correspondent Contact lon d mcilvain
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/21/1999
Decision Date 08/19/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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