The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Trudi Shaver Blade.
Device ID | K221037 |
510k Number | K221037 |
Device Name: | TruDi Shaver Blade |
Classification | Ear, Nose, And Throat Stereotaxic Instrument |
Applicant | Acclarent, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 |
Contact | Leena Zalavadia |
Correspondent | Leena Zalavadia Acclarent, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 |
Product Code | PGW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-04-07 |
Decision Date | 2022-07-20 |