DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR— 510(k) K972130

Name: FDA 510(k) clearance K972130
Creator: U.S. Food and Drug Administration
Published: 1997-10-09

Substantially Equivalent

Fairmontmedical

FDA 510(k) clearance K972130 for DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR, Substantially Equivalent on 1997-10-09. Applicant: Fairmontmedical. Device class: 2.

Clearance details

Applicant: Fairmontmedical
Product code: Code IZJ
Device class: Class 2
Regulation: 21 CFR 892.1620
Advisory panel: Radiology
Date received: 1997-06-06
Decision date: 1997-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayswater, Victoria, AU

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