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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K852938
Device Name TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK
Applicant
Northern Customfab, Inc.
P.O. Box 1336
132 Imperial Rd.
North Bay,Ont Plb 8k4 Ca,  CA
Applicant Contact S WILLIAMSON
Correspondent
Northern Customfab, Inc.
P.O. Box 1336
132 Imperial Rd.
North Bay,Ont Plb 8k4 Ca,  CA
Correspondent Contact S WILLIAMSON
Regulation Number880.5025
Classification Product Code
KPE  
Date Received07/10/1985
Decision Date 09/30/1985
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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