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510(k) K863890

Device
MAMM-AIRE
Applicant
AR CUSTOM MEDICAL PRODUCTS, LTD.
510(k) number
K863890
Product code
KXH  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-14
Date received
1986-10-06
Regulation
892.1830
Classification name
Cradle, Patient, Radiologic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES COLLETTE
Address
19a W. Industry Ct. Deer Park NY US 11729 11729

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KXH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122174PEDIATRIC POSITIONER PAD SETGe Healthcare Coils (Usa Instruments, Inc.)2012-11-16
K953246OCTOROLLOctostop, Inc.1995-09-29
K930124VARIANT OF OCTOSTOP AND OCTOPAQUEOctostop, Inc.1994-02-09
K933134SPECTRUM DG-P7000 PEDIATRIC CRADLESpectrum X-Ray Corp.1993-10-07
K930357ACCESSORY TO UNIVERSAL OCTOPAQUEOctostop, Inc.1993-07-13
K884292STRETCHER TABLEFischer Imaging Corp.1989-03-31
K840463DIGITAL CRADLESpectrum X-Ray Corp.1984-02-21
K813561SPECTRUM PEDIATRIC CARDLE TABLESpectrum X-Ray Corp.1982-01-29

Legacy Summary#

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FDA Review#

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