PREMIUM— 510(k) K011130

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K011130 for PREMIUM, Substantially Equivalent on 2001-07-05. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code ELM
Advisory panel: Dental
Date received: 2001-04-13
Decision date: 2001-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

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