The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Surgical Dynamics Discography System.
| Device ID | K921950 |
| 510k Number | K921950 |
| Device Name: | SURGICAL DYNAMICS DISCOGRAPHY SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda, CA 94501 |
| Contact | Brad Hutting |
| Correspondent | Brad Hutting SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda, CA 94501 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1993-06-07 |