PNEUMO-MATIC INSUFFLATION NEEDLE— 510(k) K970788

Name: FDA 510(k) clearance K970788
Creator: U.S. Food and Drug Administration
Published: 1997-03-27

Substantially Equivalent

Apple Medical Corp.

FDA 510(k) clearance K970788 for PNEUMO-MATIC INSUFFLATION NEEDLE, Substantially Equivalent on 1997-03-27. Applicant: Apple Medical Corp.. Device class: 2.

Clearance details

Applicant: Apple Medical Corp.
Product code: Code FHO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1997-03-04
Decision date: 1997-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bolton, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.