FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇫🇷 France
ENDOXANE
K Number: K971509
·
Decision Aug 21, 1997
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
5
Review Days
118
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Basic Information
- Device Name
- ENDOXANE
- K Number
- K971509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Novatech SA
- Date Received
- April 25, 1997
- Decision Date
- August 21, 1997
- Product Code
- NWA
- 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 |
|---|---|---|---|
| NWA | Prosthesis, Tracheal, Preformed/Molded | FDA class 2 | General, Plastic Surgery |
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