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510(k) K822348

Device
TYTAN TUBE INSERTER
Applicant
TREACE MEDICAL, INC.
510(k) number
K822348
Product code
JYM  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-07
Date received
1982-08-06
Regulation
874.4420
Classification name
Inserter, Myringotomy Tube
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 JYM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924901DEANS DISPOSABLE T-TUBE INSERTERExmoor Plastics , Ltd.1993-01-28
K870978T-TUBE INSERTERSur-Med Instruments, Inc.1987-03-19
K822349ARMSTRONG V TUBE SUCTION INSERTERTreace Medical, Inc.1982-09-13

Legacy Summary#

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FDA Review#

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