TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR
FDA 510(k) clearance K830586 · decided 1983-03-24
Clearance details
- K-number
- K830586
- Device name
- TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR
- Applicant
- Keymed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-23
- Decision date
- 1983-03-24
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KNQ
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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.