BOTTLE DECANTER— 510(k) K852778

Substantially Equivalent

Advance Medical Designs, Inc.

FDA 510(k) clearance K852778 for BOTTLE DECANTER, Substantially Equivalent on 1985-08-16. Applicant: Advance Medical Designs, Inc..

Clearance details

Applicant: Advance Medical Designs, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1985-07-01
Decision date: 1985-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.