The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Selector Ultrasonic Surgical Aspirator.
| Device ID | K901974 |
| 510k Number | K901974 |
| Device Name: | SELECTOR ULTRASONIC SURGICAL ASPIRATOR |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
| Contact | F Gibson |
| Correspondent | F Gibson SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
| 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 | 1990-05-01 |
| Decision Date | 1990-09-05 |