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 |