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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 K854346
Device Name MEDIFLEX DISPOSABLE TUBING CLAMP
Applicant
Mediflex Intl.
30 Chapin Rd. Box 2007
Pine Brook,  NJ  07058
Applicant Contact EDGAR UDINE
Correspondent
Mediflex Intl.
30 Chapin Rd. Box 2007
Pine Brook,  NJ  07058
Correspondent Contact EDGAR UDINE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/29/1985
Decision Date 11/18/1985
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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