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510(k) K832908

Device
COMFEEL PROTECTIVE RINGS
Applicant
COLOPLAST A/S
510(k) number
K832908
Product code
EYF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-12
Date received
1983-08-29
Regulation
510(k) Premarket Notification
Classification name
Protector, Wound, Plastic
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K922785IRRIVAGEAutovage1992-10-16
K911407HARDING STERNAL SHIELDHarding Medical Devices1991-07-05
K910104ANTI-FOG DISPOSABLE IV INDUCTION COVERCentral Plastic, Inc.1991-04-12
K904389SI-PRODavid F. Trungale1990-12-17

Legacy Summary#

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FDA Review#

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