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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K926435
Device Name COMFORTADE
Applicant
Sensible Products
1440 Jesusita Ln.
Santa Barbara,  CA  93105
Applicant Contact ROBERT L COTTO
Correspondent
Sensible Products
1440 Jesusita Ln.
Santa Barbara,  CA  93105
Correspondent Contact ROBERT L COTTO
Regulation Number880.5100
Classification Product Code
FNL  
Date Received12/23/1992
Decision Date 08/19/1993
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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