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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, infusion line
510(k) Number K905794
Device Name PALL 3N1 FILTER
Applicant
PALL BIOMEDICAL PRODUCTS CO.
77 CRESCENT BEACH RD.
GLEN COVE,  NY  11542
Applicant Contact EDWARD A LEMMO
Correspondent
PALL BIOMEDICAL PRODUCTS CO.
77 CRESCENT BEACH RD.
GLEN COVE,  NY  11542
Correspondent Contact EDWARD A LEMMO
Regulation Number880.5440
Classification Product Code
FPB  
Date Received12/27/1990
Decision Date 06/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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