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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 K941033
Device Name PHYSIO HAB
Applicant
Longo Industries
1800 Liberty Dr.
Pueblo,  CO  81006
Applicant Contact MATTHEW C LONGO
Correspondent
Longo Industries
1800 Liberty Dr.
Pueblo,  CO  81006
Correspondent Contact MATTHEW C LONGO
Regulation Number890.5360
Classification Product Code
ISD  
Date Received03/04/1994
Decision Date 02/27/1995
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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