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510(k) K920538

Device
PROTECTIVE RADIOGRAFIC GLOVE
Applicant
BURKHART ROENTGEN INTL., INC.
510(k) number
K920538
Product code
IWP  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-29
Date received
1992-02-05
Regulation
892.6500
Classification name
Radiographic Protective Glove
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NORMAN JACKVONY
Address
6571 43rd St., N. Unit 1704-1706 Pinellas Park FL US 34665 34665

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904878SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.Hpi, Inc.1991-03-07
K905086HPI TRI-RADS VINYL RADIATION PROTECTION GLOVESHpi, Inc.1990-12-03
K900972RADIATION PROTECTION GLOVESInfab Corp.1990-05-01
K844683IMAGEN CHLAMYDIA TESTBoots-Celltech Diagnostics, Inc.1985-02-06

Legacy Summary#

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FDA Review#

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