STRYKER VISUM SURGICAL LIGHTING SYSTEM
FDA 510(k) clearance K031068 · decided 2003-08-12
Clearance details
- K-number
- K031068
- Device name
- STRYKER VISUM SURGICAL LIGHTING SYSTEM
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2003-04-04
- Decision date
- 2003-08-12
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- FSY
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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