Device Classification Name |
system, imaging, pulsed echo, ultrasonic |
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---|---|---|---|---|
510(k) Number | K121381 | |||
Device Name | VIEWFLEX XTRA ICE CATHETER | |||
Applicant |
|
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Applicant Contact | loucinda bjorklund | |||
Correspondent |
|
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Correspodent Contact | loucinda bjorklund | |||
Regulation Number | 892.1560 | |||
Classification Product Code |
|
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Date Received | 05/08/2012 | |||
Decision Date | 06/07/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Radiology |
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510k Review Panel |
Radiology |
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summary |
summary |
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Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |