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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 K903633
Device Name ADVANCE LASER FLOWMETER, ALF 21
Applicant
Transonic Systems, Inc.
Warren Rd. Business Park
34 Dutch Mill Rd.
Ithaca,  NY  14850
Applicant Contact CORNELIS J DROST
Correspondent
Transonic Systems, Inc.
Warren Rd. Business Park
34 Dutch Mill Rd.
Ithaca,  NY  14850
Correspondent Contact CORNELIS J DROST
Regulation Number870.2100
Classification Product Code
DPW  
Date Received08/10/1990
Decision Date 10/09/1990
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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