Cleared Traditional

ANESTHESIA/RESPIRATORY FACE MASK

K953107 · Medical Marketing Concepts · Anesthesiology
Aug 1995
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K953107 is an FDA 510(k) clearance for the ANESTHESIA/RESPIRATORY FACE MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Medical Marketing Concepts (Hardy, US). The FDA issued a Cleared decision on August 15, 1995, 43 days after receiving the submission on July 3, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number K953107 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1995
Decision Date August 15, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSJ — Mask, Gas, Anesthetic
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5550

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