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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K943731
Device Name VIDEO OTOSCOPE
Applicant
Cuda Products Co.
6000 Powers Ave.
Jacksonville,  FL  32217
Applicant Contact JOSEPH CUDA
Correspondent
Cuda Products Co.
6000 Powers Ave.
Jacksonville,  FL  32217
Correspondent Contact JOSEPH CUDA
Regulation Number874.4770
Classification Product Code
ERA  
Date Received08/02/1994
Decision Date 10/11/1994
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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