The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Arthro-surgimat.
| Device ID | K962114 |
| 510k Number | K962114 |
| Device Name: | ARTHRO-SURGIMAT |
| Classification | Arthroscope |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Contact | Robert Reznick |
| Correspondent | Robert Reznick W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702002213 | K962114 | 000 |