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510(k) K891895

Device
SURGICAL LOUPES
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K891895
Product code
FSP  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-12
Date received
1989-03-24
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
ANNA STRAIGHT
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

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
K895248IMS5000 ILLUMINATED LOUPESLuxtec Corp.1989-09-15
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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