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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K093857
FOIA Releasable 510(k) K093857
Device Name C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
Applicant
Lightlab Imaging, Inc.
7 Trail House Ct.
Rockville,  MD  20850
Applicant Contact CHRISTINE BRAUER
Correspondent
Lightlab Imaging, Inc.
7 Trail House Ct.
Rockville,  MD  20850
Correspondent Contact CHRISTINE BRAUER
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Code
ORD  
Date Received12/16/2009
Decision Date 04/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT00789334
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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