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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 K890820
Device Name LOCKING WIRE GUIDE STYLET
Applicant
MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Applicant Contact FEARNOT, PHD
Correspondent
MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Correspondent Contact FEARNOT, PHD
Regulation Number878.4800
Classification Product Code
GAD  
Date Received02/17/1989
Decision Date 03/22/1989
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
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