MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
FDA 510(k) clearance K981125 · decided 1999-02-26
Clearance details
- K-number
- K981125
- Device name
- MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-27
- Decision date
- 1999-02-26
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- MSD
- 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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Recalls involving this device
No recalls on record reference this clearance.