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510(k) K993314

Device
SYNTHES LIGHT GUIDE
Applicant
SYNTHES (USA)
510(k) number
K993314
Product code
FQP  
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-06
Date received
1999-10-04
Regulation
878.4580
Classification name
Lamp, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JONATHAN GILBERT
Address
1303 Goshen Pkwy. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001223ACULUX, MODEL AX3001, AX3002Aculux2000-06-23
K781581SURGICAL LIGHT 22 SERIESAmerican Sterilizer Co.1978-10-17
K770812HANDLES, LIGHT, SURGICAL, STEOILESybron Corp.1977-05-23
K761018SURGICAL LIGHT - CHALLENGE 22 SERIESAmsco Co.1977-01-26

Legacy Summary#

summary

FDA Review#

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