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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K893969
Device Name DECUBITUS CARE PAD
Applicant
Gulftrade Exim, Inc.
1298 Som Center Rd.
Suite 102
Mayfield Heights,  OH  44124
Applicant Contact LEFFLER
Correspondent
Gulftrade Exim, Inc.
1298 Som Center Rd.
Suite 102
Mayfield Heights,  OH  44124
Correspondent Contact LEFFLER
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received06/02/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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