The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Bovie Ultrasonic Surgical System.
| Device ID | K855138 |
| 510k Number | K855138 |
| Device Name: | BOVIE ULTRASONIC SURGICAL SYSTEM |
| Classification | Device, Neurosurgical Fragmentation And Aspiration |
| Applicant | CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
| Contact | Scoville, Jr |
| Correspondent | Scoville, Jr CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
| Product Code | LBK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-11-10 |