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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K973609
Device Name IDA-4 AND IPT-MC
Applicant
BIO-TEK INSTRUMENTS, INC.
HIGHLAND PARK
P.O. BOX 998
WINOOSKI,  VT  05404 -0998
Applicant Contact MICHAEL N SEVIGNY
Correspondent
BIO-TEK INSTRUMENTS, INC.
HIGHLAND PARK
P.O. BOX 998
WINOOSKI,  VT  05404 -0998
Correspondent Contact MICHAEL N SEVIGNY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/22/1997
Decision Date 12/18/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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