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510(k) K893480

Device
BYRD EXTRACTOR SET
Applicant
MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE
510(k) number
K893480
Product code
GCC  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-23
Date received
1989-05-04
Regulation
878.4200
Classification name
Dilator, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FEARNOT, PHD
Address
P.O.Box 2402 West Lafayette IN US 47906 47906

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981061INTRAVASCULAR RETRIEVAL DEVICEMed Institute, Inc.1998-05-26
K922354BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SETMed Institute, Inc.1992-07-30
K902502BYRD STAINLESS STEEL DILATORMedical Engineering and Development Institute1990-08-07
K820865VAN-TEC FASCIAL DILATORVan-Tec, Inc.1982-05-05

Legacy Summary#

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FDA Review#

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