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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K850887
Device Name DRESSING CHANGE KIT
Applicant
Creative Care Systems, Inc.
8 Hixon Pl.
Maplewood,  NJ  07040
Applicant Contact WILLIAM A STEINHARD
Correspondent
Creative Care Systems, Inc.
8 Hixon Pl.
Maplewood,  NJ  07040
Correspondent Contact WILLIAM A STEINHARD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/04/1985
Decision Date 05/01/1985
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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