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FDA 510(k) Application Details - K191073
Device Classification Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
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510(K) Number
K191073
Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant
Vein360, LLC
4460 Lake Forest Drive
Blue Ash, OH 45242-3741 US
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Contact
Suzanne Meyer
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
NUJ
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More FDA Info for this Product Code
Date Received
04/22/2019
Decision Date
10/22/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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