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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 K933145
Device Name FIBEROPTIC LIGHTSOURCES AND CARRIERS
Applicant
Electro Fiberoptics Corp.
56 Hudson St.
Northborough,  MA  01532
Applicant Contact KENNETH DURBIN
Correspondent
Electro Fiberoptics Corp.
56 Hudson St.
Northborough,  MA  01532
Correspondent Contact KENNETH DURBIN
Regulation Number874.4350
Classification Product Code
EQH  
Date Received06/28/1993
Decision Date 09/07/1993
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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