MEDCOMP T-3
FDA 510(k) clearance K033570 · decided 2004-09-16
Clearance details
- K-number
- K033570
- Device name
- MEDCOMP T-3
- Applicant
- Medcomp
- Decision
- Substantially Equivalent
- Date received
- 2003-11-12
- Decision date
- 2004-09-16
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- NIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.