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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K881705
Device Name MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
Applicant
Surgi-Med, Inc.
815 Terminal Rd.
Lansing,  MI  48906
Applicant Contact DONALD PROPP
Correspondent
Surgi-Med, Inc.
815 Terminal Rd.
Lansing,  MI  48906
Correspondent Contact DONALD PROPP
Regulation Number890.5160
Classification Product Code
INX  
Date Received04/19/1988
Decision Date 07/13/1988
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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