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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K123987
Device Name IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
Applicant
Innovative Medical Technologies, Inc.
15059 Cedar St.
Leawood,  KS  66224
Applicant Contact BRAD BROWN
Correspondent
Innovative Medical Technologies, Inc.
15059 Cedar St.
Leawood,  KS  66224
Correspondent Contact BRAD BROWN
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/26/2012
Decision Date 08/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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