PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)— 510(k) K233777

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K233777 for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), Substantially Equivalent on 2024-05-24. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant
Primed Medical Products, Inc.
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Edmonton, CA
Download summary PDFView on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
3
Total
3

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.