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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Surgical, General & Plastic Surgery
510(k) Number K895591
Device Name SILICONE INSTRUMENT SHODS
Applicant
Key Surgical, Inc.
7101 York Ave. S.
Minneapolis,  MN  55435
Applicant Contact KAY NORDBYE
Correspondent
Key Surgical, Inc.
7101 York Ave. S.
Minneapolis,  MN  55435
Correspondent Contact KAY NORDBYE
Regulation Number878.4800
Classification Product Code
GDJ  
Date Received09/15/1989
Decision Date 10/20/1989
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
Predetermined Change
Control Plan Authorized		 No
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