FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROMEDICS SURGICAL DRILL SYSTEM
K Number: K895739
·
Decision Oct 13, 1989
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
29
Review Days
17
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Basic Information
- Device Name
- MICROMEDICS SURGICAL DRILL SYSTEM
- K Number
- K895739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micromedics, Inc.
- Date Received
- September 26, 1989
- Decision Date
- October 13, 1989
- Product Code
- HBB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
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