INSTRUMENTS FOR ONE TIME USE - DISPOSABLE— 510(k) K011514

Name: FDA 510(k) clearance K011514
Creator: U.S. Food and Drug Administration
Published: 2001-08-13

Substantially Equivalent

Kencap , Ltd.

FDA 510(k) clearance K011514 for INSTRUMENTS FOR ONE TIME USE - DISPOSABLE, Substantially Equivalent on 2001-08-13. Applicant: Kencap , Ltd.. Device class: 1.

Clearance details

Applicant: Kencap , Ltd.
Product code: Code KDD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2001-05-17
Decision date: 2001-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringwood, NJ, US

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