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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K901035
Device Name FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
Applicant
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Applicant Contact CYNTHIA ARCUSA
Correspondent
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Correspondent Contact CYNTHIA ARCUSA
Regulation Number878.4580
Classification Product Code
FST  
Date Received03/06/1990
Decision Date 04/23/1990
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
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