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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 K031153
Device Name MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065
Applicant
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact WILLIAM G MCLAIN
Correspondent
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact WILLIAM G MCLAIN
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Code
FED  
Date Received04/11/2003
Decision Date 11/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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