CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2— 510(k) K092357
Substantially EquivalentHem Con Medical Technologies, Inc.
FDA 510(k) clearance K092357 for CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2, Substantially Equivalent on 2009-08-25. Applicant: Hem Con Medical Technologies, Inc..
Clearance details
- Applicant
- Hem Con Medical Technologies, Inc.
- Product code
- Code QSY
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portland, OR, US
Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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.