NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
FDA 510(k) clearance K896118 · decided 1990-03-28
Clearance details
- K-number
- K896118
- Device name
- NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
- Applicant
- American Surgical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-23
- Decision date
- 1990-03-28
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.