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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 K912446
Device Name MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
Applicant
VASAMEDICS, L.L.C.
C/O C.G. BUNDY ASSOCIATES
6470 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
VASAMEDICS, L.L.C.
C/O C.G. BUNDY ASSOCIATES
6470 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/03/1991
Decision Date 12/12/1991
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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