RESICEM— 510(k) K080517

Substantially Equivalent

Shofu Dental Corp.

FDA 510(k) clearance K080517 for RESICEM, Substantially Equivalent on 2008-06-11. Applicant: Shofu Dental Corp.. Device class: 2.

Clearance details

Applicant
Shofu Dental Corp.
Product code
Code EMA
Device class
Class 2
Regulation
21 CFR 872.3275
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Marcos, CA, US
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