The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Sinus Balloon Inflation Device.
| Device ID | K052198 |
| 510k Number | K052198 |
| Device Name: | RELIEVA SINUS BALLOON INFLATION DEVICE |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Su-mien Chong |
| Correspondent | Su-mien Chong ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-12 |
| Decision Date | 2005-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031063574 | K052198 | 000 |