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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 K881735
Device Name CONDOM
Applicant
IRIS MEDICAL ENT., INC.
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON,  DC  20036
Applicant Contact LESLIE KUX
Correspondent
IRIS MEDICAL ENT., INC.
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON,  DC  20036
Correspondent Contact LESLIE KUX
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/22/1988
Decision Date 07/05/1988
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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