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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K103808
Device Name SAPPHIRE NC
Applicant
ORBUSNEICH MEDICAL, INC.
5363 N.W. 35TH AVE.
FT. LAUDERDALE,  FL  33309 -6315
Applicant Contact JOHN PAZIENZA
Correspondent
ORBUSNEICH MEDICAL, INC.
5363 N.W. 35TH AVE.
FT. LAUDERDALE,  FL  33309 -6315
Correspondent Contact JOHN PAZIENZA
Regulation Number870.5100
Classification Product Code
LOX  
Date Received12/29/2010
Decision Date 09/01/2011
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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