Cleared Traditional

PALL SUPOR AEF FILTER

K993379 · Pall Corp. · General Hospital
Dec 1999
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K993379 is an FDA 510(k) clearance for the PALL SUPOR AEF FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Pall Corp. (East Hills, US). The FDA issued a Cleared decision on December 16, 1999, 70 days after receiving the submission on October 7, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K993379 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1999
Decision Date December 16, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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