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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 K103128
Device Name CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
Applicant
CADWELL LAB, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact CHRIS L BOLKAN
Correspondent
CADWELL LAB, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact CHRIS L BOLKAN
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/25/2010
Decision Date 02/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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