SurgiMend PRS Meshed, Revize-X— 510(k) K171357

Substantially Equivalent

Integra Lifesciences Corporation (Owner of Tei Biosciences)

FDA 510(k) clearance K171357 for SurgiMend PRS Meshed, Revize-X, Substantially Equivalent on 2017-06-07. Applicant: Integra Lifesciences Corporation (Owner of Tei Biosciences).

Clearance details

Applicant: Integra Lifesciences Corporation (Owner of Tei Biosciences)
Product code: Code OXH
Advisory panel: General, Plastic Surgery
Date received: 2017-05-09
Decision date: 2017-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

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