The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Disposable Coronary Control Syringe.
| Device ID | K902346 |
| 510k Number | K902346 |
| Device Name: | DISPOSABLE CORONARY CONTROL SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | D Arkin |
| Correspondent | D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-25 |
| Decision Date | 1990-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848340019422 | K902346 | 000 |