ISOLIGHT— 510(k) K842358

Substantially Equivalent

Planmeca USA, Inc.

FDA 510(k) clearance K842358 for ISOLIGHT, Substantially Equivalent on 1984-07-31. Applicant: Planmeca USA, Inc.. Device class: 1.

Clearance details

Applicant: Planmeca USA, Inc.
Product code: Code EBA
Device class: Class 1
Regulation: 21 CFR 872.4630
Advisory panel: Dental
Date received: 1984-06-22
Decision date: 1984-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K842515 — SURGICAL HEADLIGHT1984-08-02

More clearances from Planmeca USA, Inc.

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K923461 — PM2002 PROLINE, PM2002 PROLINE EC1992-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.