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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K924513
Device Name LIDO(R) LINEA
Applicant
Loredan Biomedical, Inc.
3650 Industrial Blvd.
West Sacramento,  CA  95691
Applicant Contact GLEN R MANGSETH
Correspondent
Loredan Biomedical, Inc.
3650 Industrial Blvd.
West Sacramento,  CA  95691
Correspondent Contact GLEN R MANGSETH
Regulation Number890.5380
Classification Product Code
BXB  
Date Received09/04/1992
Decision Date 03/31/1993
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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