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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 K790604
Device Name CUSTOM TUBING SETS
Applicant
NORTON PERFORMANCE PLASTICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NORTON PERFORMANCE PLASTICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/19/1979
Decision Date 05/04/1979
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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