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510(k) K822373

Device
EAR SURGERY SPECULUM
Applicant
TREACE MEDICAL, INC.
510(k) number
K822373
Product code
EPY  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-09
Date received
1982-08-06
Regulation
878.1800
Classification name
Speculum, Ent
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
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 EPY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.1995-02-07
K925754ECONOMRudolf Riester GmbH & Co. KG1993-10-08
K853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.1985-12-18
K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.1984-03-06
K822370UNIVERSAL SPECULUM HOLDERTreace Medical, Inc.1982-09-09
K822164EAR SPECULIKelleher Corp.1982-08-11
K791123EAR AND NOSE SPECULAXomed, Inc.1979-07-10
K780723OTOSCOPE SPECULAAbco Dealers, Inc.1978-05-09
K772370BARRAQUER OVAL SPECULUM-VARIOUS SIZESEdward Weck, Inc.1978-01-17
K772380FARRIOR OVAL SPECULUMEdward Weck, Inc.1978-01-17
K772385THIN-BLADED NASAL SPECULUMEdward Weck, Inc.1978-01-17

Legacy Summary#

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FDA Review#

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