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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K860347
Device Name SUNLAMP MODELS 24N, 30R, 30RE, 37RE
Applicant
Gti, Inc.
314 Flanders Rd.
East Lyme,  CT  06333
Applicant Contact GERHARD FRANZ
Correspondent
Gti, Inc.
314 Flanders Rd.
East Lyme,  CT  06333
Correspondent Contact GERHARD FRANZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/29/1986
Decision Date 02/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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