Tamper Evident Cap For use with ENFit Syringes— 510(k) K170672

Substantially Equivalent

International Medical Industries, Inc.

FDA 510(k) clearance K170672 for Tamper Evident Cap For use with ENFit Syringes, Substantially Equivalent on 2017-10-06. Applicant: International Medical Industries, Inc..

Clearance details

Applicant
International Medical Industries, Inc.
Product code
Code PNR
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pompano Beach, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code PNR

product code PNR
Other
6
Total
6

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.