ANESTHESIA/RESPIRATORY DISPOSABLE MASK— 510(k) K891316

Name: FDA 510(k) clearance K891316
Creator: U.S. Food and Drug Administration
Published: 1989-08-21

Substantially Equivalent

Concord/Portex

FDA 510(k) clearance K891316 for ANESTHESIA/RESPIRATORY DISPOSABLE MASK, Substantially Equivalent on 1989-08-21. Applicant: Concord/Portex. Device class: 1.

Clearance details

Applicant: Concord/Portex
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1989-03-13
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Download summary PDF View on FDA.gov ↗

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