The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Contrast Media Sets (varying Length).
| Device ID | K900187 |
| 510k Number | K900187 |
| Device Name: | ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) |
| Classification | Set, Administration, Intravascular |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-16 |
| Decision Date | 1990-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848340019446 | K900187 | 000 |
| 10848340019439 | K900187 | 000 |