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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 K845050
Device Name UP800 A UNIVERSAL PRINTER
Applicant
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Applicant Contact DAVID E ABRAHAM
Correspondent
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Correspondent Contact DAVID E ABRAHAM
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/26/1984
Decision Date 05/29/1985
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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