CIRCULATOR BOOT— 510(k) K082134

Substantially Equivalent

Circulator Boot Corp.

FDA 510(k) clearance K082134 for CIRCULATOR BOOT, Substantially Equivalent on 2009-05-07. Applicant: Circulator Boot Corp.. Device class: 2.

Clearance details

Applicant: Circulator Boot Corp.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2008-07-29
Decision date: 2009-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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