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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 K844236
Device Name PRISTINE
Applicant
Medical Dimensions
44 Village Park Way
Santa Monica,  CA  90405
Applicant Contact JOHN MCADAMS
Correspondent
Medical Dimensions
44 Village Park Way
Santa Monica,  CA  90405
Correspondent Contact JOHN MCADAMS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/01/1984
Decision Date 11/21/1984
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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