GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)— 510(k) K961444

Substantially Equivalent

Global Medical Products, Ltd.

FDA 510(k) clearance K961444 for GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725), Substantially Equivalent on 1996-08-01. Applicant: Global Medical Products, Ltd.. Device class: 2.

Clearance details

Applicant
Global Medical Products, Ltd.
Product code
Code BSP
Device class
Class 2
Regulation
21 CFR 868.5150
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Woodbury, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BSP

product code BSP
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.