The following data is part of a premarket notification filed by Holl Meditronics, Inc. with the FDA for Sonoca Iii.
Device ID | K942095 |
510k Number | K942095 |
Device Name: | SONOCA III |
Classification | Instrument, Ultrasonic Surgical |
Applicant | HOLL MEDITRONICS, INC. 4 MARCONI COURT Bolton, Ontario, CA L7e 1e7 |
Contact | Bill H Holl |
Correspondent | Bill H Holl HOLL MEDITRONICS, INC. 4 MARCONI COURT Bolton, Ontario, CA L7e 1e7 |
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 | 1994-04-20 |
Decision Date | 1994-11-09 |