DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING— 510(k) K924277

Name: FDA 510(k) clearance K924277
Creator: U.S. Food and Drug Administration
Published: 1994-12-07

Substantially Equivalent

Chalgren Enterprises, Inc.

FDA 510(k) clearance K924277 for DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING, Substantially Equivalent on 1994-12-07. Applicant: Chalgren Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Chalgren Enterprises, Inc.
Product code: Code HLT
Device class: Class 2
Regulation: 21 CFR 886.1640
Advisory panel: Ophthalmic
Date received: 1992-08-25
Decision date: 1994-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gilroy, CA, US

Download summary PDF View on FDA.gov ↗

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