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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K851097
Device Name LODE MODEL CORIVAL ERGOMETER
Applicant
Lode Corp.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact DAN ROPER
Correspondent
Lode Corp.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact DAN ROPER
Regulation Number890.5360
Classification Product Code
ISD  
Date Received03/19/1985
Decision Date 06/18/1985
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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