FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KEY DRILL
K Number: K821127
·
Decision Jun 3, 1982
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
2
Applicant Total
4
Review Days
44
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Basic Information
- Device Name
- KEY DRILL
- K Number
- K821127
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Key Medical, Inc.
- Date Received
- April 20, 1982
- Decision Date
- June 3, 1982
- Product Code
- GFG
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GFG | Bit, Surgical | FDA class 1 | General, Plastic Surgery |
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