HEMCON BANDAGE AND HEMCON BANDAGE OTC
FDA 510(k) clearance K043050 · decided 2005-06-03
Clearance details
- K-number
- K043050
- Device name
- HEMCON BANDAGE AND HEMCON BANDAGE OTC
- Applicant
- Hemcon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-04
- Decision date
- 2005-06-03
- Days to decision
- 211 days
- Clearance type
- Abbreviated
- 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.