GENTLECARE AR APPLICATOR— 510(k) K133922

Substantially Equivalent

Gc Medtech, LLC

FDA 510(k) clearance K133922 for GENTLECARE AR APPLICATOR, Substantially Equivalent on 2014-04-18. Applicant: Gc Medtech, LLC. Device class: 2.

Clearance details

Applicant: Gc Medtech, LLC
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2013-12-23
Decision date: 2014-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lutsen, MN, US

Download summary PDF View on FDA.gov ↗

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