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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Retractor
510(k) Number K843100
Device Name INSTRUMENTS FOR MICRO ANASTOMOSIS
Applicant
DOWNS SURGICAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DOWNS SURGICAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GAD  
Date Received08/07/1984
Decision Date 09/27/1984
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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