R & D DESIGNATION AP-035— 510(k) K010414

Name: FDA 510(k) clearance K010414
Creator: U.S. Food and Drug Administration
Published: 2001-03-27

Substantially Equivalent

Jensen Industries, Inc.

FDA 510(k) clearance K010414 for R & D DESIGNATION AP-035, Substantially Equivalent on 2001-03-27. Applicant: Jensen Industries, Inc.. Device class: 2.

Clearance details

Applicant: Jensen Industries, Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2001-02-12
Decision date: 2001-03-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Haven, CT, US

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