MODIFICATION TO CAVERMAP SURGICAL AID— 510(k) K031527

Name: FDA 510(k) clearance K031527
Creator: U.S. Food and Drug Administration
Published: 2003-06-05

Substantially Equivalent

Blue Torch Medical Technologies

FDA 510(k) clearance K031527 for MODIFICATION TO CAVERMAP SURGICAL AID, Substantially Equivalent on 2003-06-05. Applicant: Blue Torch Medical Technologies. Device class: 1.

Clearance details

Applicant: Blue Torch Medical Technologies
Product code: Code FGM
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 2003-05-15
Decision date: 2003-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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