KUMAR T-ANCHORS HERNIA SET
FDA 510(k) clearance K081366 · decided 2008-07-15
Clearance details
- K-number
- K081366
- Device name
- KUMAR T-ANCHORS HERNIA SET
- Applicant
- Nashville Surgical Instruments
- Decision
- Substantially Equivalent
- Date received
- 2008-05-15
- Decision date
- 2008-07-15
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Springfield, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.