STONELITH, MODEL V5
FDA 510(k) clearance K011106 · decided 2002-02-11
Clearance details
- K-number
- K011106
- Device name
- STONELITH, MODEL V5
- Applicant
- Pck Electronic Industry and Trade Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-11
- Decision date
- 2002-02-11
- Days to decision
- 306 days
- Clearance type
- Traditional
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ankara, TR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.