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510(k) K822368

Device
CALIBRATED TISSUE GRAFT PRESS
Applicant
TREACE MEDICAL, INC.
510(k) number
K822368
Product code
JYW  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-09
Date received
1982-08-06
Regulation
874.4420
Classification name
Press, Vein
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

Legacy Summary#

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FDA Review#

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