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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 K922354
Device Name BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET
Applicant
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number878.4200
Classification Product Code
GCC  
Date Received05/19/1992
Decision Date 07/30/1992
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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