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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 K812555
Device Name DISPOSABLE SUTURE REMOVAL SCISSORS
Applicant
Medcare Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medcare Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6820
Classification Product Code
JOK  
Date Received09/08/1981
Decision Date 11/16/1981
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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