RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D— 510(k) K071173

Name: FDA 510(k) clearance K071173
Creator: U.S. Food and Drug Administration
Published: 2007-05-25

Substantially Equivalent

Ossur Americans (Formerly the Jerome Group)

FDA 510(k) clearance K071173 for RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D, Substantially Equivalent on 2007-05-25. Applicant: Ossur Americans (Formerly the Jerome Group). Device class: 2.

Clearance details

Applicant: Ossur Americans (Formerly the Jerome Group)
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 2007-04-27
Decision date: 2007-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Paulsboro, NJ, US

Download summary PDF View on FDA.gov ↗

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