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FDA 510(k) Application Details - K133282
Device Classification Name
Device, Vascular, For Promoting Embolization
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510(K) Number
K133282
Device Name
Device, Vascular, For Promoting Embolization
Applicant
REVERSE MEDICAL CORPORATION
13700 Alton Parkway
Suite 167
Irvine, CA 92618 US
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Contact
JEFFREY VALKO
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Regulation Number
870.3300
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Classification Product Code
KRD
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Date Received
10/25/2013
Decision Date
11/27/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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