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510(k) K001223

Device
ACULUX, MODEL AX3001, AX3002
Applicant
ACULUX
510(k) number
K001223
Product code
FQP  
Decision
Substantially Equivalent (SESE)
Decision date
2000-06-23
Date received
2000-04-17
Regulation
878.4580
Classification name
Lamp, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KIM MARSH
Address
273 S. Airport Pulling Rd. Naples FL US 34104 34104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993314SYNTHES LIGHT GUIDESynthes (Usa)1999-12-06
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#

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FDA Review#

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