Cleared Traditional

HAEMONETICS CELL SAVER 4 PLUS

K904041 · Haemonetics Corp. · Anesthesiology
Nov 1990
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K904041 is an FDA 510(k) clearance for the HAEMONETICS CELL SAVER 4 PLUS, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on November 13, 1990, 70 days after receiving the submission on September 4, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K904041 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1990
Decision Date November 13, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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