The following data is part of a premarket notification filed by Shandon, Inc. with the FDA for Coverslipper.
| Device ID | K780261 |
| 510k Number | K780261 |
| Device Name: | COVERSLIPPER |
| Classification | Device For Sealing Microsections |
| Applicant | SHANDON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIM |
| CFR Regulation Number | 864.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-16 |
| Decision Date | 1978-04-18 |