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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, floor standing
510(k) Number K961074
Device Name LIGHTSOURCE OR ILLUMINATOR
Applicant
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Applicant Contact KIM REED
Correspondent
CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE,  FL  32217
Correspondent Contact KIM REED
Regulation Number878.4580
Classification Product Code
FSS  
Date Received03/18/1996
Decision Date 04/30/1996
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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