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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K855132
Device Name SHAVE PREP TRAY
Applicant
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Applicant Contact MARVIN D SCHATTNER
Correspondent
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Correspondent Contact MARVIN D SCHATTNER
Regulation Number878.4800
Classification Product Code
MDM  
Date Received12/23/1985
Decision Date 01/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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