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510(k) K821487

Device
MICRO-SURGICAL POWER INSTRUMENT SYS.
Applicant
SPIRE MEDICAL, INC.
510(k) number
K821487
Product code
GFA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-02
Date received
1982-05-18
Regulation
878.4820
Classification name
Blade, Saw, General & Plastic Surgery, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID C ESSLINGER
Address
1884 Eastman Ave., #105 Ventura CA US 93003 93003

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyinc1997-06-18
K954483STRYKER SAGITTAL SAW ATTACHMENTStryker Instruments1996-01-30
K955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyinc1996-01-18
K953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.1995-07-12
K950403SURGICAL SAW BLADESTransidyne General Corp.1995-02-21
K940501RE-SHARPENABLE SAW BLADESAdven Medical1994-06-28
K933595BUR, SURGICAL, GENERAL & PLASTIC SURGERYOmega Surgical Instruments, Inc.1994-03-16
K935391SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK3M Health Care, Sarns1994-02-24
K934603SURGICAL SAW BLADESAmerican Medical Specialties, Inc.1994-02-22
K931769SNAP OSCILLATING SAWSurgiquip, Inc.1994-01-27
K934390OSCILLATING BONE SAW BLADE, 6200 SERIESBoehringer Laboratories1994-01-26
K931210INTERMEDICS ORTHOPEDICS SAW BLADEIntermedics Orthopedics1993-11-18
K933298SAW BLADEOmega Surgical Instruments, Inc.1993-08-09
K924953FLUID COOLED BONE SAW BLADE, 6000 SERIESBoehringer Laboratories1993-01-21
K912761SURGICAL SAW BLADESBlairden Precision Instruments, Inc.1991-07-19

Legacy Summary#

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FDA Review#

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