PEAK— 510(k) K152180

Substantially Equivalent

Neosil Co., Ltd.

FDA 510(k) clearance K152180 for PEAK, Substantially Equivalent on 2015-10-22. Applicant: Neosil Co., Ltd.. Device class: 2.

Clearance details

Applicant
Neosil Co., Ltd.
Product code
Code ELW
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Busan, KR
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