The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Amsis Rds, Radiographic Discography Kit.
| Device ID | K903808 |
| 510k Number | K903808 |
| Device Name: | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT |
| Classification | System, X-ray, Photofluorographic |
| Applicant | ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Contact | Ronald C Allen |
| Correspondent | Ronald C Allen ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Product Code | IZG |
| CFR Regulation Number | 892.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1991-01-22 |