The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Arthoscopy Pump A115.
| Device ID | K033927 |
| 510k Number | K033927 |
| Device Name: | ARTHOSCOPY PUMP A115 |
| Classification | Arthroscope |
| Applicant | W.O.M. WORLD OF MEDICINE AG 368 NORTH ASAPH STREET Alexandria, VA 22314 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 368 NORTH ASAPH STREET Alexandria, VA 22314 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-18 |
| Decision Date | 2004-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702002510 | K033927 | 000 |
| 04056702002428 | K033927 | 000 |