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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 K912861
Device Name FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N-
Applicant
Biocor, Inc.
102 N. College
P.O. Box 539
Tyler,  TX  75702
Applicant Contact MICKEY FOWLER
Correspondent
Biocor, Inc.
102 N. College
P.O. Box 539
Tyler,  TX  75702
Correspondent Contact MICKEY FOWLER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/27/1991
Decision Date 09/24/1991
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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