The following data is part of a premarket notification filed by Medical Vision Ab with the FDA for Powerpump Arthroscopy System.
| Device ID | K093409 |
| 510k Number | K093409 |
| Device Name: | POWERPUMP ARTHROSCOPY SYSTEM |
| Classification | Arthroscope |
| Applicant | MEDICAL VISION AB 435 RICE CREEK TERRACE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MEDICAL VISION AB 435 RICE CREEK TERRACE Fridley, MN 55432 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2010-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554037609 | K093409 | 000 |
| 17350021986792 | K093409 | 000 |
| 17350021986808 | K093409 | 000 |
| 17350021986815 | K093409 | 000 |
| 07350021981202 | K093409 | 000 |
| 07350021981523 | K093409 | 000 |
| 07350021982209 | K093409 | 000 |
| 07350021982704 | K093409 | 000 |
| 07350021983039 | K093409 | 000 |
| 17350021986778 | K093409 | 000 |
| 17350021986754 | K093409 | 000 |
| 17350021987003 | K093409 | 000 |
| 17350021987027 | K093409 | 000 |
| 17350021987058 | K093409 | 000 |
| 17350021986327 | K093409 | 000 |
| 17350021986402 | K093409 | 000 |
| 17350021986709 | K093409 | 000 |
| 17350021986730 | K093409 | 000 |
| 17350021986747 | K093409 | 000 |
| 07350021983107 | K093409 | 000 |
| 07350021983152 | K093409 | 000 |
| 07350021984340 | K093409 | 000 |
| 07350021984517 | K093409 | 000 |
| 07350021984524 | K093409 | 000 |
| 00885554037517 | K093409 | 000 |
| 00885554037524 | K093409 | 000 |
| 00885554037548 | K093409 | 000 |
| 00885554037555 | K093409 | 000 |
| 00885554037593 | K093409 | 000 |
| 07350021984272 | K093409 | 000 |
| 07350021984258 | K093409 | 000 |
| 07350021984005 | K093409 | 000 |
| 07350021984012 | K093409 | 000 |
| 07350021984043 | K093409 | 000 |
| 07350021984050 | K093409 | 000 |
| 07350021984081 | K093409 | 000 |
| 07350021984203 | K093409 | 000 |
| 07350021984210 | K093409 | 000 |
| 07350021984241 | K093409 | 000 |
| 17350021986105 | K093409 | 000 |