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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 K946041
Device Name CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)
Applicant
CARDICO, INC.
12152 WOODRUFF AVE.
DOWNEY,  CA  90241
Applicant Contact DENNIS COPELAND
Correspondent
CARDICO, INC.
12152 WOODRUFF AVE.
DOWNEY,  CA  90241
Correspondent Contact DENNIS COPELAND
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/12/1994
Decision Date 06/16/1995
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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