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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hook, Surgical, General & Plastic Surgery
510(k) Number K864425
Device Name RAYLOR(TM) DISSECTING HOOK
Applicant
Cedar Surgical, Inc.
15265 Minnetonka Blvd.
Minnetonka,  MN  55345
Applicant Contact TERRY P CORBIN
Correspondent
Cedar Surgical, Inc.
15265 Minnetonka Blvd.
Minnetonka,  MN  55345
Correspondent Contact TERRY P CORBIN
Regulation Number878.4800
Classification Product Code
GDG  
Date Received11/10/1986
Decision Date 12/12/1986
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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