The following data is part of a premarket notification filed by W.o.m. World Of Medicine Gmbh with the FDA for Arthro-pump Pa304.
| Device ID | K173311 |
| 510k Number | K173311 |
| Device Name: | ARTHRO-Pump PA304 |
| Classification | Arthroscope |
| Applicant | W.O.M. World Of Medicine GmbH Salzufer 8 Berlin, DE 10587 |
| Contact | Soeren Markworth |
| Correspondent | Soeren Markworth W.O.M. World Of Medicine GmbH Salzufer 8 Berlin, DE 10587 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-18 |
| Decision Date | 2018-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702004699 | K173311 | 000 |
| 04056702008901 | K173311 | 000 |