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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 K914775
Device Name TALLEY MICRO SYSTEM/TALLEY RIPPLEBED
Applicant
Talley Group, Ltd.
815 Terminal Rd.
Lansing,  MI  48906
Applicant Contact VAN DYKE
Correspondent
Talley Group, Ltd.
815 Terminal Rd.
Lansing,  MI  48906
Correspondent Contact VAN DYKE
Regulation Number880.5550
Classification Product Code
FNM  
Date Received10/23/1991
Decision Date 04/10/1992
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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