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510(k) K810817

Device
EXETER OPERATING LOUPE
Applicant
EXETER INSTRUMENTS, INC.
510(k) number
K810817
Product code
HOH  
Decision
Substantially Equivalent (SESE)
Decision date
1981-04-23
Date received
1981-03-24
Regulation
886.4770
Classification name
Spectacle, Operating (loupe), Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934494SURGITELGeneral Scientific Corp.1994-01-25
K875124LOW-POWER BINOCULAR LOUPESeiler Instrument & Mfg. Co., Inc.1988-02-19

Legacy Summary#

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FDA Review#

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