HISTOBRUSH— 510(k) K111681

Name: FDA 510(k) clearance K111681
Creator: U.S. Food and Drug Administration
Published: 2012-01-19

Substantially Equivalent

Puritan Medical Products Company, LLC

FDA 510(k) clearance K111681 for HISTOBRUSH, Substantially Equivalent on 2012-01-19. Applicant: Puritan Medical Products Company, LLC. Device class: 2.

Clearance details

Applicant: Puritan Medical Products Company, LLC
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2011-06-15
Decision date: 2012-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilford, ME, 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.