STRYKER ESSX MICRODEBRIDER SYSTEM
FDA 510(k) clearance K073633 · decided 2008-08-26
Clearance details
- K-number
- K073633
- Device name
- STRYKER ESSX MICRODEBRIDER SYSTEM
- Applicant
- Stryker Ireland Ltd., Instruments Division
- Decision
- Substantially Equivalent
- Date received
- 2007-12-26
- Decision date
- 2008-08-26
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Carrigtwohill, Co.Cork, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.