COLTENE PRESIDENT JET REGULAR BODY— 510(k) K882800

Name: FDA 510(k) clearance K882800
Creator: U.S. Food and Drug Administration
Published: 1988-09-23

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K882800 for COLTENE PRESIDENT JET REGULAR BODY, Substantially Equivalent on 1988-09-23. Applicant: Coltene, Inc.. Device class: 2.

Clearance details

Applicant: Coltene, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1988-07-07
Decision date: 1988-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbao, CA, US

Download summary PDF View on FDA.gov ↗

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