BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
FDA 510(k) clearance K993138 · decided 1999-10-20
Clearance details
- K-number
- K993138
- Device name
- BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
- Applicant
- Ballard Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1999-09-20
- Decision date
- 1999-10-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.