The following data is part of a premarket notification filed by Applied Polytechnology, Inc. with the FDA for Reverse-flow System.
| Device ID | K834264 |
| 510k Number | K834264 |
| Device Name: | REVERSE-FLOW SYSTEM |
| Classification | Monitor, Microbial Growth |
| Applicant | APPLIED POLYTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTA |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-01-13 |