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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Prosthesis
510(k) Number K843855
Device Name ERGOTEST 40 & 45
Applicant
Erich Jaeger, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Erich Jaeger, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3420
Classification Product Code
ISP  
Date Received10/01/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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