DISP. HYPERINFLATION BAG SYSTEM— 510(k) K813317

Name: FDA 510(k) clearance K813317
Creator: U.S. Food and Drug Administration
Published: 1982-03-12

Substantially Equivalent

Intec Medical, Inc.

FDA 510(k) clearance K813317 for DISP. HYPERINFLATION BAG SYSTEM, Substantially Equivalent on 1982-03-12. Applicant: Intec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Intec Medical, Inc.
Product code: Code NHK
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 1981-11-24
Decision date: 1982-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

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