LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
FDA 510(k) clearance K953385 · decided 1995-09-28
Clearance details
- K-number
- K953385
- Device name
- LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
- Applicant
- Walter Lorenz Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-19
- Decision date
- 1995-09-28
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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