Cleared Traditional

LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER

K880605 · Miles Laboratories, Inc. · General Hospital
May 1988
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K880605 is an FDA 510(k) clearance for the LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Miles Laboratories, Inc. (Berkeley, US). The FDA issued a Cleared decision on May 26, 1988, 104 days after receiving the submission on February 12, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K880605 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1988
Decision Date May 26, 1988
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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