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510(k) K880278

Device
MALLEABLE PTFE COATED BRAIN SPATULAE
Applicant
DOWNS SURGICAL LTD.
510(k) number
K880278
Product code
HAO  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-11
Date received
1988-01-22
Regulation
882.4535
Classification name
Instrument, Surgical, Non-powered
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEOFFREY W DOWN
Address
Pkwy. Close,Pkwy. Industrial Estate Sheffield S9 4wj GB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HAO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220920Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd.2022-09-07
K940973MULLAN GANGLION MICROCOMPRESSION SETCook, Inc.1995-09-29
K951492RIB RESECTORUnited States Surgical, A Division of Tyco Healthc1995-05-18
K943115AUTO SUTURE PITUITARY SPINAL RONGEURUnited States Surgical, A Division of Tyco Healthc1994-07-25
K942967AUTO SUTURE SPINAL CURETTEUnited States Surgical, A Division of Tyco Healthc1994-07-20
K942968AUTO SUTURE SPINAL OSTEOTOMEUnited States Surgical, A Division of Tyco Healthc1994-07-20
K942969AUTO SUTURE SPINAL NERVE HOOKUnited States Surgical, A Division of Tyco Healthc1994-07-20
K942970AUTO SUTURE SPINAL ELEVATORUnited States Surgical, A Division of Tyco Healthc1994-07-20
K942971AUTO SUTURE SPINAL DISSECTORUnited States Surgical, A Division of Tyco Healthc1994-07-20
K923723SILICONE BRAIN SPATULA SETRedmond Neurosurgical, Inc.1992-08-12
K910225BONE PAD REMOVERAcra Cut, Inc.1991-02-12
K910226DURAL DISSECTORSAcra Cut, Inc.1991-02-12
K902850ZEPPELIN INSTRUMENTSRuggles Corp.1990-07-18
K892546TAYLOR SPINAL RETRACTORZinnanti Surgical Instruments, Inc.1989-05-11
K882422DISPOSABLE ARACHNOID KNIFEMicrobio-Medics, Inc.1988-09-06

Legacy Summary#

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FDA Review#

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