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510(k) K951337

Device
FIBER HEAD LIGHT FH-300
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
510(k) number
K951337
Product code
HPQ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-08
Date received
1995-03-24
Regulation
886.4335
Classification name
Headlamp, Operating, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
YASUO KAWANO
Address
36-13, Wakamatsu-Cho, Shinjuku-Ku Tokyo JP 162-0056 162-0056

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952289WELCH ALLYN FIBER OPTIC HEADLIGNTWelch Allyn, Inc.1995-07-14
K861746KEELER DUAL LIGHTSOURCEKeeler Instruments, Inc.1986-08-21
K861747KEELER FIBEROPTIC HEADLAMPKeeler Instruments, Inc.1986-08-21
K822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDSKelleher Corp.1982-11-10

Legacy Summary#

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FDA Review#

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