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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 K993379
Device Name PALL SUPOR AEF FILTER
Applicant
PALL CORP.
2200 NORTHERN BLVD.
EAST HILLS,  NY  11548
Applicant Contact LEONARD S BERMAN
Correspondent
PALL CORP.
2200 NORTHERN BLVD.
EAST HILLS,  NY  11548
Correspondent Contact LEONARD S BERMAN
Regulation Number880.5440
Classification Product Code
FPB  
Date Received10/07/1999
Decision Date 12/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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