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 |