DeviceClearance

CELLU M6 KEYMODULE I— 510(k) K053225

Substantially Equivalent

Lpg One, Inc.

FDA 510(k) clearance K053225 for CELLU M6 KEYMODULE I, Substantially Equivalent on 2006-11-06. Applicant: Lpg One, Inc.. Device class: 1.

Clearance details

Applicant
Lpg One, Inc.
Product code
Code ISA
Device class
Class 1
Regulation
21 CFR 890.5660
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Roswell, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ISA

product code ISA
Death
3
Other
1
Total
4

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.