PREVISION CHEM— 510(k) K010541

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K010541 for PREVISION CHEM, Substantially Equivalent on 2001-07-31. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2001-02-23
Decision date: 2001-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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