TISSUE INTEGRATED PROSTHESIS DRILL
FDA 510(k) clearance K841813 · decided 1984-08-10
Clearance details
- K-number
- K841813
- Device name
- TISSUE INTEGRATED PROSTHESIS DRILL
- Applicant
- Bofors Nobelpharma, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-01
- Decision date
- 1984-08-10
- Days to decision
- 101 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
- Walker, MI, 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.