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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K852831
Device Name NON-KOR ACCESS KITS
Applicant
Creative Care Systems, Inc.
8 Hixon Pl.
Maplewood,  NJ  07040
Applicant Contact WILLIAM STEINHARD'T
Correspondent
Creative Care Systems, Inc.
8 Hixon Pl.
Maplewood,  NJ  07040
Correspondent Contact WILLIAM STEINHARD'T
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/02/1985
Decision Date 09/19/1985
Decision Substantially Equivalent - With Drug (SESD)
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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