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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Audiometer Calibration
510(k) Number K934432
Device Name OTOVIEW ENDOSCOPY SYSTEM
Applicant
Smith & Nephew Richards, Inc.
2929 Appling Rd.
Bartlett,  TN  38133
Applicant Contact RONALD K SMITH
Correspondent
Smith & Nephew Richards, Inc.
2929 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact RONALD K SMITH
Regulation Number874.1080
Classification Product Code
EWA  
Date Received09/13/1993
Decision Date 04/25/1994
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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