FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EZ 505
K Number: K844162
·
Decision Mar 11, 1985
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
2
Review Days
138
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Basic Information
- Device Name
- EZ 505
- K Number
- K844162
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Aeg Power Tool Corp.
- Date Received
- October 24, 1984
- Decision Date
- March 11, 1985
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Aeg Power Tool Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K844163 | EZ 502 | Mar 11, 1985 | Substantially Equivalent |