The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Arthro-surgimat-a103.
| Device ID | K000153 |
| 510k Number | K000153 |
| Device Name: | ARTHRO-SURGIMAT-A103 |
| 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 | 2000-01-18 |
| Decision Date | 2000-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010655882 | K000153 | 000 |
| 03596010441546 | K000153 | 000 |
| 03596010441539 | K000153 | 000 |
| 03596010441522 | K000153 | 000 |