The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Amd System Working Channel Scope And Accessories.
| Device ID | K950093 |
| 510k Number | K950093 |
| Device Name: | AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-08-15 |