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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 K953583
Device Name LUBRICATED CONDOM
Applicant
TACTYL TECHNOLOGIES, INC.
2595 COMMERCE WAY
VISTA,  CA  92083
Applicant Contact JORGE HAIDER
Correspondent
TACTYL TECHNOLOGIES, INC.
2595 COMMERCE WAY
VISTA,  CA  92083
Correspondent Contact JORGE HAIDER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/01/1995
Decision Date 01/26/1996
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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