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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 K922368
Device Name PERIFLUX PF4001 LASER DOPPLER FLOWMETER
Applicant
PERIMED, INC.
200 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3910
Applicant Contact OYSTEIN LIND
Correspondent
PERIMED, INC.
200 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3910
Correspondent Contact OYSTEIN LIND
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/20/1992
Decision Date 02/03/1993
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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