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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve
510(k) Number K934733
Device Name STIMULATING SURGICAL INSTRUMENTS
Applicant
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact RONALD K SMITH
Correspondent
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact RONALD K SMITH
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/01/1993
Decision Date 07/20/1994
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
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