The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Surgical Dynamics 30k Working Channel Scope & Instrument Set.
| Device ID | K954193 |
| 510k Number | K954193 |
| Device Name: | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET |
| Classification | Arthroscope |
| Applicant | SURGICAL DYNAMICS, INC. 2575 STANWELL DR. Concord, CA 94520 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson SURGICAL DYNAMICS, INC. 2575 STANWELL DR. Concord, CA 94520 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-10-23 |