P2 POLYETHER— 510(k) K030318

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K030318 for P2 POLYETHER, Substantially Equivalent on 2003-04-03. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2003-01-30
Decision date: 2003-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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