O2 BOOT— 510(k) K971507

Substantially Equivalent

Gwr Medical, Llp

FDA 510(k) clearance K971507 for O2 BOOT, Substantially Equivalent on 1997-11-07. Applicant: Gwr Medical, Llp. Device class: 2.

Clearance details

Applicant: Gwr Medical, Llp
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 1997-04-25
Decision date: 1997-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chadds Ford, PA, 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.