The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Uas Ultrasonic Aspirator System.
| Device ID | K971580 |
| 510k Number | K971580 |
| Device Name: | UAS ULTRASONIC ASPIRATOR SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | WELLS JOHNSON CO. 8000 S. KOLB ROAD-85706 P.O. BOX 18230 Tucson, AZ 85731 -8230 |
| Contact | Brenda Hunt |
| Correspondent | Brenda Hunt WELLS JOHNSON CO. 8000 S. KOLB ROAD-85706 P.O. BOX 18230 Tucson, AZ 85731 -8230 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-30 |
| Decision Date | 1997-12-09 |