The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Flosimple Arthroscopy Pump A120.
| Device ID | K062380 |
| 510k Number | K062380 |
| Device Name: | FLOSIMPLE ARTHROSCOPY PUMP A120 |
| Classification | Arthroscope |
| Applicant | W.O.M. WORLD OF MEDICINE AG 1490 CAMBRIDGE STREET Cambridge, MA 02139 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 1490 CAMBRIDGE STREET Cambridge, MA 02139 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-15 |
| Decision Date | 2006-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702004637 | K062380 | 000 |
| 04056702003715 | K062380 | 000 |
| 04056702003708 | K062380 | 000 |
| 04056702003692 | K062380 | 000 |
| 04056702003685 | K062380 | 000 |
| 04056702003364 | K062380 | 000 |
| 04056702002770 | K062380 | 000 |
| 04056702002756 | K062380 | 000 |