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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scissors, Medical, Disposable
510(k) Number K855131
Device Name SUTURE REMOVAL KIT
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 Number880.6820
Classification Product Code
JOK  
Date Received12/23/1985
Decision Date 01/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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