DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950— 510(k) K990371

Substantially Equivalent

Post Medical, Inc.

FDA 510(k) clearance K990371 for DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950, Substantially Equivalent on 1999-04-21. Applicant: Post Medical, Inc.. Device class: 2.

Clearance details

Applicant
Post Medical, Inc.
Product code
Code FMI
Device class
Class 2
Regulation
21 CFR 880.5570
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Atlanta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FMI

product code FMI
Death
28
Injury
1,517
Malfunction
23,981
Other
18
Total
25,544

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.