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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K120884
Device Name PERICAM PSI
Applicant
PERIMED AB
DATAVAGEN 9 A
JARFALLA,  SE 17543
Applicant Contact MARIA LILJEVRET
Correspondent
PERIMED AB
DATAVAGEN 9 A
JARFALLA,  SE 17543
Correspondent Contact MARIA LILJEVRET
Regulation Number870.2120
Classification Product Code
DPT  
Date Received03/23/2012
Decision Date 07/03/2012
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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