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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K925645
Device Name SELEC-3
Applicant
Biomedix, Inc.
23 Soutlh Main St.
P.O. Box 231
Spencer,  IN  47460
Applicant Contact DUNCAN GILMORE
Correspondent
Biomedix, Inc.
23 Soutlh Main St.
P.O. Box 231
Spencer,  IN  47460
Correspondent Contact DUNCAN GILMORE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/09/1992
Decision Date 09/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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