The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Bovie Ultrasonic Surgical Aspirator.
Device ID | K932094 |
510k Number | K932094 |
Device Name: | BOVIE ULTRASONIC SURGICAL ASPIRATOR |
Classification | Instrument, Ultrasonic Surgical |
Applicant | MDT CORP., INC. 2471 E. SHADOW WOOD CR. P.O. BOX 17801 Salt Lake City, UT 84117 |
Contact | Donald F Grabarz |
Correspondent | Donald F Grabarz MDT CORP., INC. 2471 E. SHADOW WOOD CR. P.O. BOX 17801 Salt Lake City, UT 84117 |
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 | 1993-04-30 |
Decision Date | 1993-07-21 |