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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter
510(k) Number K893480
Device Name BYRD EXTRACTOR SET
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 Number878.4200
Classification Product Code
GCC  
Date Received05/04/1989
Decision Date 06/23/1989
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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