LEKSELL GAMMAPLAN
FDA 510(k) clearance K973441 · decided 1998-04-01
Clearance details
- K-number
- K973441
- Device name
- LEKSELL GAMMAPLAN
- Applicant
- Patterson Consulting Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-11
- Decision date
- 1998-04-01
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- IWB
- Device class
- 2
- Regulation number
- 892.5750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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