A2J MZ 44 LASER LIGHT FOR POSITIONING— 510(k) K872894

Name: FDA 510(k) clearance K872894
Creator: U.S. Food and Drug Administration
Published: 1987-08-12

Substantially Equivalent

Prometex, Inc.

FDA 510(k) clearance K872894 for A2J MZ 44 LASER LIGHT FOR POSITIONING, Substantially Equivalent on 1987-08-12. Applicant: Prometex, Inc.. Device class: 1.

Clearance details

Applicant: Prometex, Inc.
Product code: Code IWE
Device class: Class 1
Regulation: 21 CFR 892.5780
Advisory panel: Radiology
Date received: 1987-07-23
Decision date: 1987-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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