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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K080174
Device Name PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
Applicant
Cardio Med Supplies, Inc.
199 St. David St.
Lindsay-Ontario,  CA K9V 5K7
Applicant Contact CHRISTIAN G DUBE
Correspondent
Cardio Med Supplies, Inc.
199 St. David St.
Lindsay-Ontario,  CA K9V 5K7
Correspondent Contact CHRISTIAN G DUBE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/24/2008
Decision Date 04/23/2008
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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