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510(k) K192998

Device
Reprocessed BRK Transseptal Needle
Applicant
Innovative Health, LLC.
510(k) number
K192998
Product code
NMK  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-22
Date received
2019-10-28
Regulation
870.1390
Classification name
Trocar, Reprocessed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Amanda Babcock
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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