The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Vulcan Articular Cartilage Probe, Model 721xxxx.
| Device ID | K050898 |
| 510k Number | K050898 |
| Device Name: | SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Karen Provencher |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-11 |
| Decision Date | 2005-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010001580 | K050898 | 000 |