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510(k) K864775

Device
CHISEL (OSTEOTOME, GOUGE, ETC.)
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
510(k) number
K864775
Product code
EMM  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-12
Date received
1986-12-05
Regulation
872.4565
Classification name
Chisel, Osteotome, Surgical
Medical specialty
Dental
Review panel
Dental
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 EMM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963897STERI-OSS SINUS AUGMENTATION KITSteri-Oss, Inc.1996-11-06
K851714820/1 TO 820/51 VARIOUS TYPES BONE RONGEURSArtiberia1985-06-11
K760959SURGICAL CHISELAmerican Safety Equipment Corp.1976-11-15

Legacy Summary#

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FDA Review#

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