The following data is part of a premarket notification filed by Holl Meditronics, Inc. with the FDA for Sonoca Ultrasonic Surgical System.
Device ID | K893926 |
510k Number | K893926 |
Device Name: | SONOCA ULTRASONIC SURGICAL SYSTEM |
Classification | Instrument, Ultrasonic Surgical |
Applicant | HOLL MEDITRONICS, INC. P.O. BOX 396 Bolton, Ontario, CA L7e 5t3 |
Contact | William H Holl |
Correspondent | William H Holl HOLL MEDITRONICS, INC. P.O. BOX 396 Bolton, Ontario, CA L7e 5t3 |
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 | 1989-05-31 |
Decision Date | 1989-11-14 |