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510(k) K852541

Device
STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
Applicant
STORZ INSTRUMENT CO.
510(k) number
K852541
Product code
GFI  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-11
Date received
1985-06-14
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
DAN REAGAN
Address
3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

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
K891887OSTEOTOMES, VARIOUS TYPESZinnanti Surgical Instruments, Inc.1989-04-12
K842823CHERMEL OSTEOTOMESCher Mel Corp.1984-08-02

Legacy Summary#

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FDA Review#

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