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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, suction, single patient use, portable, nonpowered
510(k) Number K850634
Device Name SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
Applicant
SURGIDYNE, INC.
6975 WASHINGTON AVE.
SUITE 200
MINNEAPOLIS,  MN  55435
Applicant Contact CHARLES B MCNEIL
Correspondent
SURGIDYNE, INC.
6975 WASHINGTON AVE.
SUITE 200
MINNEAPOLIS,  MN  55435
Correspondent Contact CHARLES B MCNEIL
Regulation Number878.4680
Classification Product Code
GCY  
Date Received02/19/1985
Decision Date 06/28/1985
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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