Cleared Traditional

SAGE 2200 STERILE SPECIMEN CONTAINER

K813408 · Sage Products, Inc. · Radiology
Jan 1982
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K813408 is an FDA 510(k) clearance for the SAGE 2200 STERILE SPECIMEN CONTAINER, a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1982, 49 days after receiving the submission on December 7, 1981. This device falls under the Radiology review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K813408 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1981
Decision Date January 25, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code FMT — Warmer, Infant Radiant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5130

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