JARIT RECOMMENDED SINUS INSTRUMENTS— 510(k) K941565

Substantially Equivalent

J. Jamner Surgical Instruments, Inc.

FDA 510(k) clearance K941565 for JARIT RECOMMENDED SINUS INSTRUMENTS, Substantially Equivalent on 1994-05-16. Applicant: J. Jamner Surgical Instruments, Inc..

Clearance details

Applicant
J. Jamner Surgical Instruments, Inc.
Product code
Code EOB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hawthorne, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

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.