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510(k) K883575

Device
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
Applicant
SITE MICROSURGICAL SYSTEMS, INC.
510(k) number
K883575
Product code
HMG  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-12
Date received
1988-08-22
Regulation
886.1860
Classification name
Stand, Instrument, Ophthalmic, Non-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES K MCCRACKEN
Address
135 Gibraltar Rd. Horsham PA US 19044 19044

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K900161A-SCAN ROLL-AROUND STANDJedmed Instrument Co.1990-02-16
K873554GORSK INSTRUMENT RESTGorsk, Inc.1987-10-23
K841759OPHTHALMIC TABLEWoodlyn, Inc.1984-06-01

Legacy Summary#

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FDA Review#

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