The following data is part of a premarket notification filed by Tek Marketing, Inc. with the FDA for Micro-max, Model 319.
| Device ID | K002404 |
| 510k Number | K002404 |
| Device Name: | MICRO-MAX, MODEL 319 |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | TEK MARKETING, INC. 98 RAILROAD DR. Warminster, PA 18974 -1454 |
| Contact | John A Hope |
| Correspondent | John A Hope TEK MARKETING, INC. 98 RAILROAD DR. Warminster, PA 18974 -1454 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-08-30 |