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510(k) K870758

Device
SMALL MASTOID RETRACTOR
Applicant
TREACE MEDICAL, INC.
510(k) number
K870758
Product code
KAL  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-04
Date received
1987-02-26
Regulation
874.4420
Classification name
Retractor, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS, JR
Address
Suite 400 22 N. Second St. Memphis TN US 38103 38103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KAL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K833604ADJUSTABLE FORK RETRACTORMicrotek Medical, Inc.1984-01-03
K772381RING HANDLE & RETRACTORSEdward Weck, Inc.1978-01-17
K772392ALLPORT MASTOID RETRACTORSEdward Weck, Inc.1978-01-17
K760851CONVERSE ALTAR RETRACTORV. Mueller O.V. Baxter Healthcare Corp.1977-03-10

Legacy Summary#

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FDA Review#

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