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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 K844499
Device Name MEDSENTRY SOFTOUCH SYSTEM
Applicant
Medsentry Corp.
690 El Rancho Rd.
Santa Barbara,  CA  93108
Applicant Contact SUSAN F BROWNE
Correspondent
Medsentry Corp.
690 El Rancho Rd.
Santa Barbara,  CA  93108
Correspondent Contact SUSAN F BROWNE
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/20/1984
Decision Date 01/30/1985
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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