TUBING, AXIOM SILICONE PENROSE— 510(k) K781749

Name: FDA 510(k) clearance K781749
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K781749 for TUBING, AXIOM SILICONE PENROSE, Substantially Equivalent on 1978-12-04. Applicant: Axiom Medical, Inc.. Device class: 2.

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code KDH
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1978-10-17
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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