Cleared Traditional

ALPHA MICRON 20 MICROAGGREGATE FILTER

K955515 · Alpha Therapeutic Corp. · General Hospital
Feb 1996
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K955515 is an FDA 510(k) clearance for the ALPHA MICRON 20 MICROAGGREGATE FILTER, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Alpha Therapeutic Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 12, 1996, 70 days after receiving the submission on December 4, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K955515 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1995
Decision Date February 12, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAK — Microfilter, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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