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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K885324
Device Name HEMA(PRO)TEC(TION)
Applicant
Medical Products Search, Inc.
2596 Reynolda Rd.
Suite D
Winston-Salem,  NC  27106
Applicant Contact MICHAEL P BRADLEY
Correspondent
Medical Products Search, Inc.
2596 Reynolda Rd.
Suite D
Winston-Salem,  NC  27106
Correspondent Contact MICHAEL P BRADLEY
Regulation Number864.6150
Classification Product Code
GIO  
Date Received12/28/1988
Decision Date 02/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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