The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for 30-cs01, 30-cs02, 30-cs03 Control Syringes.
| Device ID | K894801 |
| 510k Number | K894801 |
| Device Name: | 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES |
| Classification | Syringe, Piston |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Thomas E Cottone |
| Correspondent | Thomas E Cottone 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 | 1989-07-28 |
| Decision Date | 1989-09-19 |