The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Arthro-surgimat-2000 Ecu.
| Device ID | K990443 |
| 510k Number | K990443 |
| Device Name: | ARTHRO-SURGIMAT-2000 ECU |
| Classification | Arthroscope |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST. Mansfield, MA 02048 |
| Contact | Michael Mcgrail |
| Correspondent | Michael Mcgrail W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST. Mansfield, MA 02048 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-11 |
| Decision Date | 1999-02-26 |
| Summary: | summary |