The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set.
| Device ID | K990213 |
| 510k Number | K990213 |
| Device Name: | HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-22 |
| Decision Date | 1999-02-02 |
| Summary: | summary |