The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Sonopet Iq Ultrasonic Aspirator System.
Device ID | K213824 |
510k Number | K213824 |
Device Name: | Sonopet IQ Ultrasonic Aspirator System |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Stryker Corporation 4100 East Milham Ave. Kalamazoo, MI 49001 |
Contact | Thomas Flannelly |
Correspondent | Thomas Flannelly Stryker Corporation 4100 East Milham Ave. Kalamazoo, MI 49001 |
Product Code | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-08 |
Decision Date | 2022-02-03 |