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510(k) K052663

Device
INO THERAPEUTICS INOBLENDER, MODEL 10004
Applicant
INO THERAPEUTICS
510(k) number
K052663
Product code
MRO  
Decision
Substantially Equivalent (SESE)
Decision date
2005-11-04
Date received
2005-09-27
Regulation
868.5165
Classification name
Apparatus, Nitric Oxide, Backup Delivery
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FREDERICK MONTGOMERY
Address
7601-B Murphy Dr. Middleton WI US 53562 53562

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122689INOBLENDERIno Therapeutics2012-11-07
K011874FADASIS MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.2001-07-20
K003665FADASSI MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.2001-02-23

Legacy Summary#

summary

FDA Review#

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