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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K801015
Device Name PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
Applicant
Kimble-Terumo, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kimble-Terumo, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1675
Classification Product Code
GIM  
Date Received04/29/1980
Decision Date 05/14/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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