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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name protector, transducer, dialysis
510(k) Number K863496
Device Name MEDIFLEX TRANSDUCER PROTECTOR
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 Number876.5820
Classification Product Code
FIB  
Date Received09/09/1986
Decision Date 09/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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