FDA 510(K), K141313 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
FDA 510(K), K141313 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K141313
Device Name REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
Applicant REVERSE MEDICAL CORPORATION
Regulation Number 870.3300
Classification Product Code KRD
Date Received 05/20/2014
Decision Date 06/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
Total pages: 120
Fully redacted pages: 72
Content pages: 48
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