PIEZOELECTRIC SYSTEM— 510(k) K100410

Substantially Equivalent

Satelec

FDA 510(k) clearance K100410 for PIEZOELECTRIC SYSTEM, Substantially Equivalent on 2010-04-28. Applicant: Satelec. Device class: 2.

Clearance details

Applicant: Satelec
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2010-02-16
Decision date: 2010-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

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