PENTAX FLEXIBLE DRIODENOFIBERSCOPE— 510(k) K812810

Name: FDA 510(k) clearance K812810
Creator: U.S. Food and Drug Administration
Published: 1981-11-17

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K812810 for PENTAX FLEXIBLE DRIODENOFIBERSCOPE, Substantially Equivalent on 1981-11-17. Applicant: Pentax Precision Instrument Corp.. Device class: 2.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FAK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1981-10-06
Decision date: 1981-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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