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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wire, Guide, Catheter
510(k) Number K002962
Device Name PRESSURE WIRE SENSOR, MODEL 12003/12303
Applicant
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA,  SE S-754 50
Applicant Contact MATS GRANLUND
Correspondent
RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA,  SE S-754 50
Correspondent Contact MATS GRANLUND
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/22/2000
Decision Date 10/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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