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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K780302
Device Name BLOOD FLOWMETER SYSTEM
Applicant
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medtronic Vascular
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/22/1978
Decision Date 04/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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