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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 K910788
Device Name CMI TENDER TOUCH VE #303TT AND 404TT
Applicant
CHALLENGE MFG., INC.
P.O. BOX 5877
BEND,  OR  97708
Applicant Contact EMILY SMITH
Correspondent
CHALLENGE MFG., INC.
P.O. BOX 5877
BEND,  OR  97708
Correspondent Contact EMILY SMITH
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/25/1991
Decision Date 05/09/1991
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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