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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, Endoscopic
510(k) Number K934337
Device Name CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
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
FSW  
Date Received09/07/1993
Decision Date 11/18/1993
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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