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510(k) K070457

Device
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
Applicant
SUN SCIENTIFIC LLC
510(k) number
K070457
Product code
MHW  
Decision
Substantially Equivalent (SESE)
Decision date
2007-05-16
Date received
2007-02-16
Regulation
880.5075
Classification name
Dressing, Compression
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH AZARY
Address
543 Long Hill Ave. Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912765STASIS BUTTON PRSSURE DEVICEArch Development Group1991-08-12

Legacy Summary#

summary

FDA Review#

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