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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K950191
Device Name THE LOTECON PERSONAL CARE SYSTEM
Applicant
Lotecon, Inc.
100 Tower Dr. #15
Greenville,  SC  29607
Applicant Contact WILLIAM M HARGEST
Correspondent
Lotecon, Inc.
100 Tower Dr. #15
Greenville,  SC  29607
Correspondent Contact WILLIAM M HARGEST
Regulation Number880.5550
Classification Product Code
FNM  
Date Received01/17/1995
Decision Date 06/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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