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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 K893491
Device Name MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
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 Received05/04/1989
Decision Date 06/22/1989
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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