The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Ent Irrigating Pump (70327700).
| Device ID | K973286 |
| 510k Number | K973286 |
| Device Name: | ENT IRRIGATING PUMP (70327700) |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Deborah A Arthur |
| Correspondent | Deborah A Arthur GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-09-29 |
| Summary: | summary |