PHARMULATOR— 510(k) K896990

Substantially Equivalent

Acacia, Inc.

FDA 510(k) clearance K896990 for PHARMULATOR, Substantially Equivalent on 1990-03-23. Applicant: Acacia, Inc..

Clearance details

Applicant
Acacia, Inc.
Product code
Code LHI
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Loma Linda, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LHI

product code LHI
Injury
207
Malfunction
7,820
Other
3
Total
8,030

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.