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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 K895603
Device Name S.S.T. SURGICAL THIMBLE
Applicant
Healthcare Technologies Resources, Inc.
3160 N. Truckee Ln.,
Suite 21
Sparks,  NV  89431
Applicant Contact MICHAEL E FISHER
Correspondent
Healthcare Technologies Resources, Inc.
3160 N. Truckee Ln.,
Suite 21
Sparks,  NV  89431
Correspondent Contact MICHAEL E FISHER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/18/1989
Decision Date 10/06/1989
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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