The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Yankauer Suction Device.
| Device ID | K905478 |
| 510k Number | K905478 |
| Device Name: | YANKAUER SUCTION DEVICE |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Brian E Larson |
| Correspondent | Brian E Larson MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-06 |
| Decision Date | 1990-12-19 |