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510(k) K963897

Device
STERI-OSS SINUS AUGMENTATION KIT
Applicant
STERI-OSS, INC.
510(k) number
K963897
Product code
EMM  
Decision
Substantially Equivalent (SESE)
Decision date
1996-11-06
Date received
1996-09-27
Regulation
872.4565
Classification name
Chisel, Osteotome, Surgical
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DON KENNARD
Address
22895 Eastpark Dr. Yorba Linda CA US 92887 92887

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
K864775CHISEL (OSTEOTOME, GOUGE, ETC.)New England Surgical Instrument Corp.1987-02-12
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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