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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Ear, Nose And Throat
510(k) Number K953096
Device Name ESSENTIAL SHAVER SYSTEM
Applicant
Smith & Nephew Richards, Inc.
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact DEBORAH A ARTHUR
Correspondent
Smith & Nephew Richards, Inc.
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact DEBORAH A ARTHUR
Regulation Number874.4140
Classification Product Code
EQJ  
Subsequent Product Code
ERL  
Date Received07/03/1995
Decision Date 07/28/1995
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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