HYPODERMIC NEEDLES & SYRINGES— 510(k) K821348

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K821348 for HYPODERMIC NEEDLES & SYRINGES, Substantially Equivalent on 1982-06-10. Applicant: Medi-Tech, Inc..

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1982-05-05
Decision date: 1982-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.