The following data is part of a premarket notification filed by Pan Medical Ltd with the FDA for Inter V Kyphoplasty Catheter (balloon Length: 0 Mm), Interv Kyphoplasty Catheter (balloon Lenght: 15 Mm), Interv Kyphopl.
| Device ID | K132620 |
| 510k Number | K132620 |
| Device Name: | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | PAN MEDICAL LTD BARNETT WAY, BARNWOOD Gloucester, Gloucestershire, GB Gl4 3rt |
| Contact | Jennie Budding |
| Correspondent | Jennie Budding PAN MEDICAL LTD BARNETT WAY, BARNWOOD Gloucester, Gloucestershire, GB Gl4 3rt |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-21 |
| Decision Date | 2014-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033860037826 | K132620 | 000 |
| 08033860030193 | K132620 | 000 |
| 08033860030186 | K132620 | 000 |
| 08033860030179 | K132620 | 000 |