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510(k) K923187

Device
IMPERVIOUS ISOLATION SHOE COVERS
Applicant
DYNATECH MEDICAL PRODUCTS
510(k) number
K923187
Product code
FXW  
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-29
Date received
1992-06-30
Regulation
878.4040
Classification name
Shoes, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MITCHELL DAVIS
Address
605 White Hills Dr. Rockwall TX US 75087 75087

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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