EXPAZEN
FDA 510(k) clearance K150423 · decided 2015-07-08
Clearance details
- K-number
- K150423
- Device name
- EXPAZEN
- Applicant
- Produits Dentaires Pierre Rolland (Acteon Group)
- Decision
- Substantially Equivalent
- Date received
- 2015-02-19
- Decision date
- 2015-07-08
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- MVL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Merignac, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.