PROSPECTOR PLUS (CODE NAME : RD-0508)— 510(k) K973881

Name: FDA 510(k) clearance K973881
Creator: U.S. Food and Drug Administration
Published: 1997-11-24

Substantially Equivalent

J.F. Jelenko & Co., Inc.

FDA 510(k) clearance K973881 for PROSPECTOR PLUS (CODE NAME : RD-0508), Substantially Equivalent on 1997-11-24. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.

Clearance details

Applicant: J.F. Jelenko & Co., Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1997-10-14
Decision date: 1997-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

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