The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Ana-disc System.
| Device ID | K820308 |
| 510k Number | K820308 |
| Device Name: | ANA-DISC SYSTEM |
| Classification | Device, Gas Generating |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-04 |
| Decision Date | 1982-03-04 |