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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, X-Ray, Fluorographic, Cine Or Spot
510(k) Number K972130
Device Name DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
Applicant
Fairmontmedical
4/21 Malvern St.
Bayswater, Victoria,  AU 3153
Applicant Contact JOANN MCBAIN
Correspondent
Fairmontmedical
4/21 Malvern St.
Bayswater, Victoria,  AU 3153
Correspondent Contact JOANN MCBAIN
Regulation Number892.1620
Classification Product Code
IZJ  
Date Received06/06/1997
Decision Date 10/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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