SIGHTSURE OPERATION INDICATOR, MODEL SS301
FDA 510(k) clearance K993358 · decided 2000-03-15
Clearance details
- K-number
- K993358
- Device name
- SIGHTSURE OPERATION INDICATOR, MODEL SS301
- Applicant
- Medevices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-06
- Decision date
- 2000-03-15
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Grayslake, 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.