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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K854940
Device Name TIPS AND PADS, CANE,CRUTCH AND WALKER
Applicant
Healthtech Industries, Inc.
3121 Gardenbrook Dr.
Farmers Branch,  TX  75234
Applicant Contact CARLA BELLER
Correspondent
Healthtech Industries, Inc.
3121 Gardenbrook Dr.
Farmers Branch,  TX  75234
Correspondent Contact CARLA BELLER
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received12/10/1985
Decision Date 01/30/1986
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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