The following data is part of a premarket notification filed by Neuro Therm, Inc. with the FDA for Parallax Balloon Inflatable Bone Tamp-10 Mm Balloon Parallax Balloon Inflatable Bone Tamp-15 Mm Balloon Parallax Balloon.
| Device ID | K122503 |
| 510k Number | K122503 |
| Device Name: | PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | NEURO THERM, INC. 200 Homer Ave Ashland, MA 01721 |
| Contact | F. David Rothkopf |
| Correspondent | F. David Rothkopf NEURO THERM, INC. 200 Homer Ave Ashland, MA 01721 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2013-06-25 |
| Summary: | summary |