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FDA 510(k) Application Details - K192998
Device Classification Name
Trocar, Reprocessed
More FDA Info for this Device
510(K) Number
K192998
Device Name
Trocar, Reprocessed
Applicant
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
Scottsdale, AZ 85257 US
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Contact
Amanda Babcock
Other 510(k) Applications for this Contact
Regulation Number
870.1390
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Classification Product Code
NMK
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More FDA Info for this Product Code
Date Received
10/28/2019
Decision Date
07/22/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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