GUIDEWIRE
FDA 510(k) clearance K921200 · decided 1992-09-04
Clearance details
- K-number
- K921200
- Device name
- GUIDEWIRE
- Applicant
- Lake Region Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-12
- Decision date
- 1992-09-04
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- KNY
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.