The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Halo 360 & Sizing Balloon, Model 3441c.
| Device ID | K093855 |
| 510k Number | K093855 |
| Device Name: | HALO 360 & SIZING BALLOON, MODEL 3441C |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Contact | Viorica Filimon |
| Correspondent | Viorica Filimon BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521189355 | K093855 | 000 |