AM-100 I/A AMPAC— 510(k) K860770

Substantially Equivalent

Dravon Medical, Inc.

FDA 510(k) clearance K860770 for AM-100 I/A AMPAC, Substantially Equivalent on 1986-04-21. Applicant: Dravon Medical, Inc..

Clearance details

Applicant: Dravon Medical, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1986-03-03
Decision date: 1986-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.