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510(k) K894785

Device
Surgical Chisel/osteotome
Applicant
FDT PRECISION MACHINE CO., INC.
510(k) number
K894785
Product code
KDG
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-18
Date received
1989-07-27
Regulation
878.4820
Classification name
Chisel (Osteotome)
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALLEN P SCHLEIN
Address
650 Clinton Ave. Bridgeport CT US 06605 06605

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952678STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KITAvail-Southwest Division1995-07-10
K952200OMNI-JUGWaterstone Medical, Inc.1995-06-29
K891471SIL-MED WASTE FLUID DUMP BAGSil-Med Corp.1989-08-15
K872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSPorex Medical1987-08-21
K872092OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5Military Engineering, Inc.1987-06-23
K842824CHERMEL BONE CHISELSCher Mel Corp.1984-08-02
K772373ANDERSON-NEIVERT OSTEOTOMEEdward Weck, Inc.1978-03-09
K772374SILVER OSTEOTOMEEdward Weck, Inc.1978-03-09
K772376NEIVERT OSTEOTOMEEdward Weck, Inc.1978-03-09
K780135CEMENT EXTRACTION INSTRUMENT SETOrthopedic Equipment Co., Inc.1978-01-31