The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Acclarent Se Inflation Device.
| Device ID | K150172 |
| 510k Number | K150172 |
| Device Name: | ACCLARENT SE Inflation Device |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DRIVE Menlo Park, CA 94025 |
| Contact | James Patrick Garvey Ii |
| Correspondent | James Patrick Garvey Ii ACCLARENT, INC. 1525-B O'BRIEN DRIVE Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031230863 | K150172 | 000 |
| 30705031230860 | K150172 | 000 |