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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 K972009
Device Name PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE
Applicant
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Applicant Contact EDWARD MARKOVIC
Correspondent
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Correspondent Contact EDWARD MARKOVIC
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/30/1997
Decision Date 09/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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