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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K940222
Device Name SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
Applicant
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact NEAL DEFIBAUGH
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact NEAL DEFIBAUGH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/18/1994
Decision Date 06/29/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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