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510(k) K912765

Device
STASIS BUTTON PRSSURE DEVICE
Applicant
ARCH DEVELOPMENT GROUP
510(k) number
K912765
Product code
MHW  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-12
Date received
1991-06-24
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A ROTH
Address
9648 Olive Blvd., Suite 411 St. Louis MO US 63132 63132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070457SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFABSun Scientific, LLC2007-05-16

Legacy Summary#

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FDA Review#

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