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510(k) K844180

Device
THE MCP-70-SE SYSTEM
Applicant
ELLIS PHARMACEUTICAL CONSULTING, INC.
510(k) number
K844180
Product code
KQA  
Decision
Substantially Equivalent (SESE)
Decision date
1985-02-01
Date received
1984-10-26
Regulation
892.5900
Classification name
Device, Beam Limiting, X-ray, Therapeutic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEVI ELLIS
Address
913 State Rd. Princeton NJ US 08540 08540

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
K914784PAPILLION PROCTOSCOPEOldelft Corp. of America1992-06-05
K885126PHILIPS RT250 COLLIMATOR (PK8050)Perkins Mfg. Co.1989-06-01
K790168COLLIMATOR, BILATERIALCmsi1979-02-15

Legacy Summary#

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FDA Review#

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