FDA.reportPublic FDA data

510(k) K891887

Device
OSTEOTOMES, VARIOUS TYPES
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K891887
Product code
GFI  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-12
Date received
1989-03-24
Regulation
878.4800
Classification name
Osteotome, Manual
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANNA STRAIGHT
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933181VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500Valleylab, Inc.1993-11-02
K932534ISI FENESTRATED DISSECTING AND GRASPING FORCEPSInnovative Surgical, Inc.1993-08-19
K920001HEMOLAB SILIMAT REAGENTBiomerieux Vitek, Inc.1992-09-25
K852541STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURSStorz Instrument Co.1985-07-11
K842823CHERMEL OSTEOTOMESCher Mel Corp.1984-08-02

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases