The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Dropper, Solution Trichrome, Cepti-seal.
| Device ID | K781062 |
| 510k Number | K781062 |
| Device Name: | DROPPER, SOLUTION TRICHROME, CEPTI-SEAL |
| Classification | Stain, Trichrome, Mallory's |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HYW |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-26 |
| Decision Date | 1978-08-14 |