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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular occluding, temporary
510(k) Number K121785
Device Name SCEPTER C OCCLUSION BALLOON CATHETER
Applicant
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Applicant Contact Naomi Gong
Correspondent
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Correspondent Contact Naomi Gong
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Code
DQY  
Date Received06/18/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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