The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Ultrasonic Straight/ultrasonic Knife/ultrasonic Ring Currette.
Device ID | K020220 |
510k Number | K020220 |
Device Name: | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE |
Classification | Instrument, Ultrasonic Surgical |
Applicant | SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
Contact | Sue Oster |
Correspondent | Sue Oster SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
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 | 2002-01-22 |
Decision Date | 2002-08-23 |
Summary: | summary |