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510(k) K823916

Device
WAX CURETTE TIP
Applicant
TREACE MEDICAL, INC.
510(k) number
K823916
Product code
JYG  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-21
Date received
1982-12-28
Regulation
874.4420
Classification name
Curette, Ear
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
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 JYG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932609EAR CURETTEEar Tech, Inc.1993-07-21
K852039FLEX-LOOP FLEXIBLE EAR CORETTEBionix Corp.1985-06-11
K841354CURETTETreace Medical, Inc.1984-07-06
K841001EAR CURETTE, VARIOUSPremier Dental Products Co.1984-05-29
K822273ENT CURRETTESKelleher Corp.1982-08-30
K822006OPERATIVE EAR CURRETTES & RELATED ITEMKelleher Corp.1982-08-12

Legacy Summary#

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FDA Review#

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