The following data is part of a premarket notification filed by Safkan, Inc. with the FDA for Otoset- Ear Cleaning System.
| Device ID | K201877 |
| 510k Number | K201877 |
| Device Name: | OtoSet- Ear Cleaning System |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | SafKan, Inc. 1665 E 18th Street #205 Tucson, AZ 85719 |
| Contact | Sahil Diwan |
| Correspondent | Allison Komiyama Acknowledge Regulatory Strategies, LLC 2251 San Diego Avenue Ste B-257 San Diego, CA 92110 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2020-11-05 |