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510(k) K872209

Device
ARTHROPLASTY MALLET
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
510(k) number
K872209
Product code
HXL  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-23
Date received
1987-06-09
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
RICHARD M BEANE
Address
P.O. Box 35 83 E. Water St. Rockland MA US 02370 02370

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
K882349MALLET, SURGICALTreace Medical, Inc.1988-06-23
K871195MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.Military Engineering, Inc.1987-04-06

Legacy Summary#

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FDA Review#

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