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510(k) K922348

Device
VALTRAC(R) INTRODUCER FORCEP
Applicant
AMERICAN CYANAMID CO.
510(k) number
K922348
Product code
HJE  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-09
Date received
1992-05-19
Regulation
878.4580
Classification name
Lamp, Fluorescein, Ac-powered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN J TAMSETT
Address
One Casper St. Danbury CT US 06810 06810

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802291FLUORESCENT SUN LAMP FIXTUREStrato-Ray Co.1980-10-31
K781698EXAMINER 10American Sterilizer Co.1978-11-03

Legacy Summary#

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FDA Review#

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