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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K091444
Device Name PERFSCAPE
Applicant
OLEA MEDICAL
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact NEAL KOLBER
Correspondent
OLEA MEDICAL
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact NEAL KOLBER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/15/2009
Decision Date 07/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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