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510(k) K883480

Device
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
Applicant
SITE MICROSURGICAL SYSTEMS, INC.
510(k) number
K883480
Product code
FCT  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-24
Date received
1988-08-16
Regulation
886.4335
Classification name
Headlight, Fiberoptic Focusing
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
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 FCT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960767LIGHT COMMANDERScieran Technologies, Inc.1996-08-26
K924198MODIFIED SITE FIBER OPTIC MODULEChiron Vision Corp.1992-11-23
K802769FIBER OPTIC HEADLIGHT #60-0765Aspen Laboratories, Inc.1980-12-11
K802770FIBER OPTIC HEADLIGHT #60-0766766Aspen Laboratories, Inc.1980-12-11
K780433FIBER OPTIC ADJUSTABLE HEADLIGHTCameron-Miller, Inc.1978-06-13

Legacy Summary#

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FDA Review#

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