RESECTOSCOPE SHEATH
FDA 510(k) clearance K931994 · decided 1994-02-17
Clearance details
- K-number
- K931994
- Device name
- RESECTOSCOPE SHEATH
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-23
- Decision date
- 1994-02-17
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.