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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Examination, Medical, Battery Powered
510(k) Number K841589
Device Name C-LITE
Applicant
Suncoast Medical Manufacturers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Suncoast Medical Manufacturers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6350
Classification Product Code
KYT  
Date Received04/18/1984
Decision Date 05/22/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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