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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
Predetermined Change
Control Plan Authorized		 No
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