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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K955464
Device Name TACTYLON POWDER FREE EXAMINATION GLOVE
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 Number880.6250
Classification Product Code
LZA  
Date Received11/30/1995
Decision Date 04/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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