The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Clarity Ultrasonic Surgical Aspirator System.
Device ID | K221835 |
510k Number | K221835 |
Device Name: | CUSA Clarity Ultrasonic Surgical Aspirator System |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Integra Lifesciences Corporation 1100 Campus Road Princeton, NJ 08540 |
Contact | Alexandra Wells |
Correspondent | Alexandra Wells Integra Lifesciences Corporation 1100 Campus Road Princeton, NJ 08540 |
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 | 2022-06-23 |
Decision Date | 2022-08-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30381780536363 | K221835 | 000 |
10381780536352 | K221835 | 000 |