The following data is part of a premarket notification filed by Physicians Supply Co. with the FDA for Ear Irrigation Set 101 (earigator).
| Device ID | K884786 |
| 510k Number | K884786 |
| Device Name: | EAR IRRIGATION SET 101 (EARIGATOR) |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | PHYSICIANS SUPPLY CO. 2963 EAST FALLENTINE RD. Sandy, UT 84092 |
| Contact | Diehl, M.d. |
| Correspondent | Diehl, M.d. PHYSICIANS SUPPLY CO. 2963 EAST FALLENTINE RD. Sandy, UT 84092 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1989-04-26 |