INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
FDA 510(k) clearance K011514 · decided 2001-08-13
Clearance details
- K-number
- K011514
- Device name
- INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
- Applicant
- Kencap , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-17
- Decision date
- 2001-08-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KDD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ringwood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.