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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 K913654
Device Name SMITH AND DAVIS PRESSURE THERAPY SYSTEM
Applicant
Smith & Davis Mfg. Co.
1180 Central Industrial Ave.
St Louis,  MO  63110
Applicant Contact DARRELL MCENTIRE
Correspondent
Smith & Davis Mfg. Co.
1180 Central Industrial Ave.
St Louis,  MO  63110
Correspondent Contact DARRELL MCENTIRE
Regulation Number890.5160
Classification Product Code
INX  
Date Received08/16/1991
Decision Date 11/22/1991
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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