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510(k) K071028

Device
VIEWMATE SYSTEM
Applicant
EP MEDSYSTEMS
510(k) number
K071028
Product code
ITN  
Decision
Substantially Equivalent (SESE)
Decision date
2007-05-01
Date received
2007-04-11
Regulation
890.3675
Classification name
Splint, Denis Brown
Medical specialty
Physical Medicine
Review panel
Radiology
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LARRY PICCIANO
Address
Cooper Run Executive Park 575 Rte. 73 N., Bldg. D West Berlin NJ US 08091 08091

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ITN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K032669Y.E.S. POWERED WHEELCHAIR, MODEL T200Yeou Eir Shuen Machinery Co., Ltd.2003-11-12
K821256COUNTER-ROTATION SYSTEMThe Langer Group1982-06-23

Legacy Summary#

summary

FDA Review#

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