ENDOXANE
FDA 510(k) clearance K971509 · decided 1997-08-21
Clearance details
- K-number
- K971509
- Device name
- ENDOXANE
- Applicant
- Novatech SA
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1997-04-25
- Decision date
- 1997-08-21
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- NWA
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Aubagne, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.