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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K904378
Device Name F.T.I. MEDICAL LIGHT GUIDE
Applicant
Fiberoptics Technology, Inc.
1 Fiber Rd.
Pomfret,  CT  06258
Applicant Contact ALLEN GUILLOTTE
Correspondent
Fiberoptics Technology, Inc.
1 Fiber Rd.
Pomfret,  CT  06258
Correspondent Contact ALLEN GUILLOTTE
Regulation Number874.4350
Classification Product Code
EQH  
Date Received09/24/1990
Decision Date 01/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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