ERB ENDORECTAL BALLOON— 510(k) K141958

Substantially Equivalent

Edge Medical, LLC

FDA 510(k) clearance K141958 for ERB ENDORECTAL BALLOON, Substantially Equivalent on 2014-11-18. Applicant: Edge Medical, LLC. Device class: 2.

Clearance details

Applicant: Edge Medical, LLC
Product code: Code PCT
Device class: Class 2
Regulation: 21 CFR 892.5720
Advisory panel: Radiology
Date received: 2014-07-18
Decision date: 2014-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lutsen, MN, US

Download summary PDF View on FDA.gov ↗

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