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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
510(k) Number K871116
Device Name X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
Applicant
X-Cel X-Ray Corp.
4220 Waller Dr., P.O. Box 1857
Crystal Lake,  IL  60039 -1857
Applicant Contact WILLIAM W MORRIS
Correspondent
X-Cel X-Ray Corp.
4220 Waller Dr., P.O. Box 1857
Crystal Lake,  IL  60039 -1857
Correspondent Contact WILLIAM W MORRIS
Regulation Number892.5900
Classification Product Code
IYH  
Date Received03/19/1987
Decision Date 05/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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