The following data is part of a premarket notification filed by Holl Meditronics, Inc. with the FDA for Sonoca Ii Ultrasonic Surgical Device.
Device ID | K901737 |
510k Number | K901737 |
Device Name: | SONOCA II ULTRASONIC SURGICAL DEVICE |
Classification | Instrument, Ultrasonic Surgical |
Applicant | HOLL MEDITRONICS, INC. 241 EAST MADISON AVE. Collingswood, NJ 08108 |
Contact | David Purdon |
Correspondent | David Purdon HOLL MEDITRONICS, INC. 241 EAST MADISON AVE. Collingswood, NJ 08108 |
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 | 1990-04-17 |
Decision Date | 1990-07-03 |