ACCU-BEAM TUBE SET
FDA 510(k) clearance K921208 · decided 1993-06-01
Clearance details
- K-number
- K921208
- Device name
- ACCU-BEAM TUBE SET
- Applicant
- Tti Medical
- Decision
- Substantially Equivalent
- Date received
- 1992-03-12
- Decision date
- 1993-06-01
- Days to decision
- 446 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.