IMPAX 5000— 510(k) K934386

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K934386 for IMPAX 5000, Substantially Equivalent on 1994-01-05. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1993-09-08
Decision date: 1994-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

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