The following data is part of a premarket notification filed by Plastic Injectors, Inc. with the FDA for Code-a-well.
| Device ID | K841390 |
| 510k Number | K841390 |
| Device Name: | CODE-A-WELL |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | PLASTIC INJECTORS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-05-02 |