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510(k) K790949

Device
GALVANIC UNIT
Applicant
RAMI INTERNATIONAL CORP.
510(k) number
K790949
Product code
ISB  
Decision
Substantially Equivalent (SESE)
Decision date
1979-08-16
Date received
1979-05-21
Regulation
890.1850
Classification name
Stimulator, Muscle, Diagnostic
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ISB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842805IMPULS 3, IT SELECTORRobert Bosch Corp.1984-08-01
K842262PIRD-YPirdy, Inc.1984-06-28
K780632MAXICEPTORMed General1978-08-14
K780730FIGURETRIMJay-Mar INternational Enterprises, IN1978-05-09

Legacy Summary#

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FDA Review#

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