SIGMOIDOSCOPE, FLEXIBLE
FDA 510(k) clearance K822765 · decided 1982-11-17
Clearance details
- K-number
- K822765
- Device name
- SIGMOIDOSCOPE, FLEXIBLE
- Applicant
- Harvard Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1982-09-14
- Decision date
- 1982-11-17
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FAM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, 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.