CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
FDA 510(k) clearance K090026 · decided 2009-03-31
Clearance details
- K-number
- K090026
- Device name
- CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
- Applicant
- Hem Con Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-05
- Decision date
- 2009-03-31
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.