510(k) K842405— DR. GOULD HAND PACK SUSTOM STERIL

Substantially Equivalent

Pro-Lab, Inc.

Clearance details

Applicant: Pro-Lab, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1984-06-19
Decision date: 1984-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.