FLUID BARRIER BOOT KNEE & ANKLE-HIGH— 510(k) K955835

Name: FDA 510(k) clearance K955835
Creator: U.S. Food and Drug Administration
Published: 1996-11-19

Substantially Equivalent

Instrument Makar, Inc.

FDA 510(k) clearance K955835 for FLUID BARRIER BOOT KNEE & ANKLE-HIGH, Substantially Equivalent on 1996-11-19. Applicant: Instrument Makar, Inc.. Device class: 1.

Clearance details

Applicant: Instrument Makar, Inc.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1995-12-26
Decision date: 1996-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Okemos, MI, 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.