POLLY'S VITREOUS SCISSORS J-225-S— 510(k) K922355

Substantially Equivalent

O.R. Specialties, Inc.

FDA 510(k) clearance K922355 for POLLY'S VITREOUS SCISSORS J-225-S, Substantially Equivalent on 1992-08-18. Applicant: O.R. Specialties, Inc..

Clearance details

Applicant
O.R. Specialties, Inc.
Product code
Code HQE
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuscaloosa, AL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HQE

product code HQE
Injury
156
Malfunction
565
Total
721

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.