HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
FDA 510(k) clearance K990213 · decided 1999-02-02
Clearance details
- K-number
- K990213
- Device name
- HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
- Applicant
- Gyrus Ent LLC
- Decision
- Substantially Equivalent
- Date received
- 1999-01-22
- Decision date
- 1999-02-02
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.