AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK— 510(k) K951043

Name: FDA 510(k) clearance K951043
Creator: U.S. Food and Drug Administration
Published: 1995-06-07

Substantially Equivalent

Promedic, Inc.

FDA 510(k) clearance K951043 for AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK, Substantially Equivalent on 1995-06-07. Applicant: Promedic, Inc.. Device class: 1.

Clearance details

Applicant: Promedic, Inc.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1995-03-07
Decision date: 1995-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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