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510(k) K895248

Device
IMS5000 ILLUMINATED LOUPES
Applicant
LUXTEC CORP.
510(k) number
K895248
Product code
FSP  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-15
Date received
1989-08-21
Regulation
878.4800
Classification name
Loupe, Diagnostic/surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE K PACKARD
Address
P.O. Box 225, Rte. 20/49 Techno Park Rd. Sturbridge MA US 01566 01566

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891895SURGICAL LOUPESZinnanti Surgical Instruments, Inc.1989-04-12
K864386LUXTEC LOUPES FOR SURGICAL VISIONLuxtec Corp.1986-11-17
K8617493X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCEKeeler Instruments, Inc.1986-05-23

Legacy Summary#

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FDA Review#

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