Cleared Traditional

PHARMASSURE LARGE VOLUME TRANSFER FILTERS

K943127 · Gelman Sciences, Inc. · General Hospital
Sep 1994
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K943127 is an FDA 510(k) clearance for the PHARMASSURE LARGE VOLUME TRANSFER FILTERS, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on September 29, 1994, 92 days after receiving the submission on June 29, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K943127 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1994
Decision Date September 29, 1994
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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