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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K896676
Device Name KEY VASCULAR LOOPS
Applicant
KEY SURGICAL, INC.
7101 YORK AVENUE SOUTH
MINNEAPOLIS,  MN  55435 -4450
Applicant Contact KAY NORDBYE
Correspondent
KEY SURGICAL, INC.
7101 YORK AVENUE SOUTH
MINNEAPOLIS,  MN  55435 -4450
Correspondent Contact KAY NORDBYE
Regulation Number878.4800
Classification Product Code
KDC  
Date Received11/27/1989
Decision Date 02/27/1990
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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