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FDA 510(k) Application Details - K182735
Device Classification Name
System&Accessories,Isolated Heart,Transport&Preservation
More FDA Info for this Device
510(K) Number
K182735
Device Name
System&Accessories,Isolated Heart,Transport&Preservation
Applicant
Paragonix Technologies
639 Granite Street #408
Braintree, MA 02184 US
Other 510(k) Applications for this Company
Contact
Lisa M. Anderson
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
MSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2018
Decision Date
10/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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