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510(k) K031660

Device
FERRIS POLYMEM STERILE BREAST PAD
Applicant
FERRIS MFG. CORP.
510(k) number
K031660
Product code
NTX  
Decision
Substantially Equivalent (SESE)
Decision date
2005-02-22
Date received
2003-05-28
Regulation
880.5630
Classification name
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THEODORE R THORSEN
Address
16 W. 300 83rd St. Burr Ridge IL US 60527 60527

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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