EMS SURFACE MOUNT SCALER
FDA 510(k) clearance K991874 · decided 1999-07-30
Clearance details
- K-number
- K991874
- Device name
- EMS SURFACE MOUNT SCALER
- Applicant
- (Ems Sa) Electro Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-06-02
- Decision date
- 1999-07-30
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.