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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 K911431
Device Name TACTYLON(TM) CONDOM
Applicant
Tactyl Technologies, Inc.
2595 Commerce Way
Vista,  CA  92083
Applicant Contact BUDDENHAGEN
Correspondent
Tactyl Technologies, Inc.
2595 Commerce Way
Vista,  CA  92083
Correspondent Contact BUDDENHAGEN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/02/1991
Decision Date 12/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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