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510(k) K914784

Device
PAPILLION PROCTOSCOPE
Applicant
OLDELFT CORP. OF AMERICA
510(k) number
K914784
Product code
KQA  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-05
Date received
1991-10-23
Regulation
892.5900
Classification name
Device, Beam Limiting, X-ray, Therapeutic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHARLES PATTIE
Address
2735 Dorr Ave. Fairfax VA US 22031 22031

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K885126PHILIPS RT250 COLLIMATOR (PK8050)Perkins Mfg. Co.1989-06-01
K844180THE MCP-70-SE SYSTEMEllis Pharmaceutical Consulting, Inc.1985-02-01
K790168COLLIMATOR, BILATERIALCmsi1979-02-15

Legacy Summary#

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FDA Review#

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