The following data is part of a premarket notification filed by Engineering & Research Associates, Inc. with the FDA for Heat Sealing Devices.
| Device ID | BK910026 |
| 510k Number | BK910026 |
| Device Name: | Heat Sealing Devices |
| Classification | Device, Heat-sealing |
| Applicant | Engineering & Research Associates, Inc. 500 North Tucson Boulevard (era Plaza) Tucson, AZ 85716 |
| Product Code | KSD |
| CFR Regulation Number | 864.9750 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1992-11-05 |