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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 K854020
Device Name G-T 1000
Applicant
G-T Products
11 Oakhaven Dr.
Haleyville,  AL  35565
Applicant Contact GEORGE DENNIS
Correspondent
G-T Products
11 Oakhaven Dr.
Haleyville,  AL  35565
Correspondent Contact GEORGE DENNIS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/30/1985
Decision Date 11/15/1985
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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