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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K932166
Device Name SILICONE TYMPANOSTOMY TUBES
Applicant
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact JEFF COBB
Correspondent
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact JEFF COBB
Regulation Number874.3880
Classification Product Code
ETD  
Date Received05/04/1993
Decision Date 07/26/1993
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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