DeviceClearance

MALLET— 510(k) K841627

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841627 for MALLET, Substantially Equivalent on 1984-08-27. Applicant: Plastafil, Inc.. Device class: 1.

Clearance details

Applicant
Plastafil, Inc.
Product code
Code HWA
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
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 HWA

product code HWA
Malfunction
12,146
Other
2
Total
12,148

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.