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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Catheter
510(k) Number K855039
Device Name MEDIFLEX INJECTION CAP
Applicant
MEDIFLEX INTL.
30 CHAPIN RD. BOX 2007
PINE BROOK,  NJ  07058
Correspondent
MEDIFLEX INTL.
30 CHAPIN RD. BOX 2007
PINE BROOK,  NJ  07058
Regulation Number878.4200
Classification Product Code
GCE  
Date Received12/17/1985
Decision Date 01/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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