IMPAX 1000— 510(k) K933409

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K933409 for IMPAX 1000, Substantially Equivalent on 1993-11-03. 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: 1993-07-12
Decision date: 1993-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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