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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Powered
510(k) Number K952441
Device Name LEGEND
Applicant
Health Care Mfg., Inc.
2146 E. Pythian St.
Springfield,  MO  65802
Applicant Contact RODNEY MOULDER
Correspondent
Health Care Mfg., Inc.
2146 E. Pythian St.
Springfield,  MO  65802
Correspondent Contact RODNEY MOULDER
Regulation Number890.3760
Classification Product Code
INQ  
Date Received05/25/1995
Decision Date 06/19/1995
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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