SRI PLR GOWN
FDA 510(k) clearance K080707 · decided 2008-11-13
Clearance details
- K-number
- K080707
- Device name
- SRI PLR GOWN
- Applicant
- Sri/Surgical Express
- Decision
- Substantially Equivalent
- Date received
- 2008-03-12
- Decision date
- 2008-11-13
- Days to decision
- 246 days
- Clearance type
- Abbreviated
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.