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510(k) K911407

Device
HARDING STERNAL SHIELD
Applicant
HARDING MEDICAL DEVICES
510(k) number
K911407
Product code
EYF  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-05
Date received
1991-03-29
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#

Contact
BRIDGET HARDING
Address
P.O. Box 10151 Greensboro NC US 27404 27404

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
K910104ANTI-FOG DISPOSABLE IV INDUCTION COVERCentral Plastic, Inc.1991-04-12
K904389SI-PRODavid F. Trungale1990-12-17
K832908COMFEEL PROTECTIVE RINGSColoplast A/S1983-12-12

Legacy Summary#

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FDA Review#

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