QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
FDA 510(k) clearance K080680 · decided 2008-03-21
Clearance details
- K-number
- K080680
- Device name
- QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
- Applicant
- Surgical Specialties Corp
- Decision
- Substantially Equivalent
- Date received
- 2008-03-10
- Decision date
- 2008-03-21
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Herndon, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.