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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K902831
Device Name TACTYLON TM SURGICAL GLOVE
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 Number878.4460
Classification Product Code
KGO  
Date Received06/28/1990
Decision Date 07/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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