HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
FDA 510(k) clearance K111575 · decided 2012-05-23
Clearance details
- K-number
- K111575
- Device name
- HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
- Applicant
- Orthocon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-06
- Decision date
- 2012-05-23
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Irvington, NY, 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.