GAUDERER GASTROSTOMY BUTTON
FDA 510(k) clearance K843392 · decided 1984-10-11
Clearance details
- K-number
- K843392
- Device name
- GAUDERER GASTROSTOMY BUTTON
- Applicant
- American V. Mueller
- Decision
- Substantially Equivalent
- Date received
- 1984-08-29
- Decision date
- 1984-10-11
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.