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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K855160
Device Name CARE IV BURN PAD, CATALOG #'S BP2334,BP3472
Applicant
Howard Associates, Inc.
6600 Lbj Fwy. #4145
Dallas,  TX  75240
Applicant Contact HOWARD
Correspondent
Howard Associates, Inc.
6600 Lbj Fwy. #4145
Dallas,  TX  75240
Correspondent Contact HOWARD
Date Received12/26/1985
Decision Date 01/24/1986
Decision Substantially Equivalent (SESE)
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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