The following data is part of a premarket notification filed by Plasti-products, Inc. with the FDA for Disposa-spec.
| Device ID | K840593 |
| 510k Number | K840593 |
| Device Name: | DISPOSA-SPEC |
| Classification | Otoscope |
| Applicant | PLASTI-PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-09 |
| Decision Date | 1984-07-13 |