OPTISON ULTRASONIC SCALER
FDA 510(k) clearance K837382 · decided 1983-05-06
Clearance details
- K-number
- K837382
- Device name
- OPTISON ULTRASONIC SCALER
- Applicant
- Pelton & Crane Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-04
- Decision date
- 1983-05-06
- Days to decision
- 63 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Charlotte, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.