The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Arthro-surgimat-1500.
| Device ID | K983910 |
| 510k Number | K983910 |
| Device Name: | ARTHRO-SURGIMAT-1500 |
| 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 | 1998-11-03 |
| Decision Date | 1998-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702002923 | K983910 | 000 |
| 04056702002916 | K983910 | 000 |