XPS DRILL SYSTEM
FDA 510(k) clearance K983224 · decided 1998-10-21
Clearance details
- K-number
- K983224
- Device name
- XPS DRILL SYSTEM
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-14
- Decision date
- 1998-10-21
- Days to decision
- 37 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
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.