LIQUID NITROGEN SPRAY UNIT— 510(k) K772232

Substantially Equivalent

Gilmore Liquid Air Co.

FDA 510(k) clearance K772232 for LIQUID NITROGEN SPRAY UNIT, Substantially Equivalent on 1977-12-15. Applicant: Gilmore Liquid Air Co.. Device class: 2.

Clearance details

Applicant
Gilmore Liquid Air Co.
Product code
Code GEH
Device class
Class 2
Regulation
21 CFR 878.4350
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEH

product code GEH
Death
25
Injury
351
Malfunction
901
Total
1,277

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.