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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K820980
Device Name BIOPSY FORCEPS W/OVAL CUP & NEEDLE
Applicant
MILL-ROSE LABORATORY
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MILL-ROSE LABORATORY
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GEN  
Date Received04/06/1982
Decision Date 04/26/1982
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
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