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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, partial ossicular replacement
510(k) Number K003214
Device Name SMITH & NEPHEW PISTONS
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact JEFFREY W COBB
Correspondent
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact JEFFREY W COBB
Regulation Number874.3450
Classification Product Code
ETB  
Date Received10/13/2000
Decision Date 10/31/2000
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
Recalls CDRH Recalls
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