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510(k) K961444

Device
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
Applicant
GLOBAL MEDICAL PRODUCTS, LTD.
510(k) number
K961444
Product code
BSP  
Decision
Substantially Equivalent (SESE)
Decision date
1996-08-01
Date received
1996-04-15
Regulation
868.5150
Classification name
Needle, Conduction, Anesthetic (w/wo Introducer)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PETER CLARK
Address
244 Main St., S. P.O. Box 505 Woodbury CT US 06798 06798

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243690SonoMSKPAJUNK GmbH Medizintechnologie2025-07-01
K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie2025-06-27
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie2025-06-25
K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie2025-03-24
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie2024-11-22
K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie2024-09-11
K240253Reach NeedleAerin Medical, Inc.2024-03-21
K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited2022-07-29
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company2022-07-01
K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBecton, Dickinson and Company2021-12-22
K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal NeedlesMyco Medical Supplies, Inc.2021-09-29
K212328DiscCath Needle SetDisccath, LLC2021-09-26
K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit NeedleBecton, Dickinson and Company2020-09-29
K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.2020-05-27
K191290Ancora Nerve Block Catheter SetAncora Medical Technology2020-02-06

Legacy Summary#

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FDA Review#

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