BRIGHTSTAR
FDA 510(k) clearance K981081 · decided 1998-04-29
Clearance details
- K-number
- K981081
- Device name
- BRIGHTSTAR
- Applicant
- Hill-Rom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-24
- Decision date
- 1998-04-29
- Days to decision
- 36 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
- Batesville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.