COLLASORB COLLAGEN WOUND DRESSING— 510(k) K091338

Substantially Equivalent

Hartmann-Conco, Inc.

FDA 510(k) clearance K091338 for COLLASORB COLLAGEN WOUND DRESSING, Substantially Equivalent on 2009-08-26. Applicant: Hartmann-Conco, Inc..

Clearance details

Applicant
Hartmann-Conco, Inc.
Product code
Code KGN
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Crofton, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KGN

product code KGN
Other
2
Total
2

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.