FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TISSUE INTEGRATED PROSTHESIS DRILL
K Number: K841813
·
Decision Aug 10, 1984
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
3
Review Days
101
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Basic Information
- Device Name
- TISSUE INTEGRATED PROSTHESIS DRILL
- K Number
- K841813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Bofors Nobelpharma, Inc.
- Date Received
- May 1, 1984
- Decision Date
- August 10, 1984
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
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