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510(k) K823915

Device
MIRROR TIP
Applicant
TREACE MEDICAL, INC.
510(k) number
K823915
Product code
KAI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-21
Date received
1982-12-28
Regulation
874.4420
Classification name
Mirror, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KAI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K833601ANTRUM & ATTIC MIRRORMicrotek Medical, Inc.1984-01-03
K822374BUCKINGHAM ATTIC & ANTRUM MIRRORTreace Medical, Inc.1982-09-09
K822261LARYNGEAL MIRRORSKelleher Corp.1982-08-30
K822191HEAD MIRROR WITH HEADBANDKelleher Corp.1982-08-20
K820354ATMOS MIRROR WARMERJedmed Instrument Co.1982-03-01
K781750MIRROR WARMERArleton Technical Products, Inc.1979-01-17
K770053MIRROR, LARYNGEALWelch Allyn, Inc.1977-01-18
K770054MIRROR, NASO-PHARYNXWelch Allyn, Inc.1977-01-18

Legacy Summary#

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FDA Review#

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