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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 K972538
Device Name FLOW-EZE BLUNT CANNULA (1999BC)
Applicant
Acacia, Inc.
P.O. Box 1799
Ojai,  CA  93023
Applicant Contact JAMES J SULLIVAN
Correspondent
Acacia, Inc.
P.O. Box 1799
Ojai,  CA  93023
Correspondent Contact JAMES J SULLIVAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/08/1997
Decision Date 07/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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