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510(k) K832950

Device
SCIENTRONICS 10K EYE MAGNET
Applicant
SCIENTIFIC MANUFACTURER
510(k) number
K832950
Product code
HPO  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-19
Date received
1983-08-31
Regulation
886.4440
Classification name
Magnet, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854870INTRAOCULAR ELECTROMAGNETMira, Inc.1986-02-19
K830336DORC INTRAOCULAR ELECTROMAGNETJedmed Instrument Co.1983-03-09

Legacy Summary#

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FDA Review#

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