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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K002200
Device Name CAPELLA
Applicant
Madsen Electronics, Inc.
5600 Rowland Rd., Suite 275
Minnetonka,  MN  55343
Applicant Contact JIM BERGERSON
Correspondent
Madsen Electronics, Inc.
5600 Rowland Rd., Suite 275
Minnetonka,  MN  55343
Correspondent Contact JIM BERGERSON
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/20/2000
Decision Date 08/25/2000
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
Predetermined Change
Control Plan Authorized		 No
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