FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HANAULUX(R) 2000
K Number: K895715
·
Decision Oct 13, 1989
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
2
Review Days
18
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Basic Information
- Device Name
- HANAULUX(R) 2000
- K Number
- K895715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- W.C. Heraeus GmbH
- Date Received
- September 25, 1989
- Decision Date
- October 13, 1989
- Product Code
- FTD
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by W.C. Heraeus GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K875078 | HERACURE LS 500 | Feb 22, 1988 | Substantially Equivalent |