Flap Fixator, Burr Hole Cover— 510(k) K192310

Substantially Equivalent

Ossaware Biotech Co., Ltd.

FDA 510(k) clearance K192310 for Flap Fixator, Burr Hole Cover, Substantially Equivalent on 2020-06-03. Applicant: Ossaware Biotech Co., Ltd..

Clearance details

Applicant: Ossaware Biotech Co., Ltd.
Product code: Code GXR
Advisory panel: Neurology
Date received: 2019-08-26
Decision date: 2020-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenkang Hsiang, TW

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