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510(k) K851714

Device
820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS
Applicant
ARTIBERIA
510(k) number
K851714
Product code
EMM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-11
Date received
1985-04-25
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
GIL M SANCHEZ
Address
4518 Los Ranchitos San Antonio TX US 78233 78233

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
K864775CHISEL (OSTEOTOME, GOUGE, ETC.)New England Surgical Instrument Corp.1987-02-12
K760959SURGICAL CHISELAmerican Safety Equipment Corp.1976-11-15

Legacy Summary#

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FDA Review#

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