The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact, Models 306/307.
| Device ID | K820338 |
| 510k Number | K820338 |
| Device Name: | IMPACT, MODELS 306/307 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | IMPACT INSTRUMENTATION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-08 |
| Decision Date | 1982-03-02 |