LIC INSTRUMENT PROCESSING SYSTEM
FDA 510(k) clearance K101158 · decided 2011-05-06
Clearance details
- K-number
- K101158
- Device name
- LIC INSTRUMENT PROCESSING SYSTEM
- Applicant
- Langford IC Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-26
- Decision date
- 2011-05-06
- Days to decision
- 375 days
- Clearance type
- Traditional
- Product code
- FEB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.