GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR— 510(k) K844613

Substantially Equivalent

Packaging Technologies, Inc.

FDA 510(k) clearance K844613 for GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR, Substantially Equivalent on 1985-01-10. Applicant: Packaging Technologies, Inc..

Clearance details

Applicant
Packaging Technologies, Inc.
Product code
Code FSM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FSM

product code FSM
Malfunction
1,289
Total
1,289

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.