The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Bovie Ultrasonic Surgical Aspirator, Model Me2000.
| Device ID | K880166 |
| 510k Number | K880166 |
| Device Name: | BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | CLINICAL TECHNOLOGY CORP. 1212 ST. PAUL ST. Baltimore, MD 21202 |
| Contact | Frank Bonadio |
| Correspondent | Frank Bonadio CLINICAL TECHNOLOGY CORP. 1212 ST. PAUL ST. Baltimore, MD 21202 |
| 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 | 1988-01-14 |
| Decision Date | 1988-02-18 |