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510(k) K882349

Device
MALLET, SURGICAL
Applicant
TREACE MEDICAL, INC.
510(k) number
K882349
Product code
HXL  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-23
Date received
1988-06-07
Regulation
878.4800
Classification name
Mallet
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM H 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 HXL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872209ARTHROPLASTY MALLETNew England Surgical Instrument Corp.1987-06-23
K871195MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.Military Engineering, Inc.1987-04-06

Legacy Summary#

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FDA Review#

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