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510(k) K820865

Device
VAN-TEC FASCIAL DILATOR
Applicant
VAN-TEC, INC.
510(k) number
K820865
Product code
GCC  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-05
Date received
1982-03-29
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#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K893480BYRD EXTRACTOR SETMedical Engineering and Development Institute1989-06-23

Legacy Summary#

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FDA Review#

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