LASER BACKPOINTER ASSEMBLY, MOD. 01-2487— 510(k) K800489

Name: FDA 510(k) clearance K800489
Creator: U.S. Food and Drug Administration
Published: 1980-03-25

Substantially Equivalent

Atc Medical Technology, Inc.

FDA 510(k) clearance K800489 for LASER BACKPOINTER ASSEMBLY, MOD. 01-2487, Substantially Equivalent on 1980-03-25. Applicant: Atc Medical Technology, Inc.. Device class: 1.

Clearance details

Applicant: Atc Medical Technology, Inc.
Product code: Code IWE
Device class: Class 1
Regulation: 21 CFR 892.5780
Advisory panel: Radiology
Date received: 1980-03-04
Decision date: 1980-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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