The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Dropper, Cepti-seal Koh Solution.
| Device ID | K781869 |
| 510k Number | K781869 |
| Device Name: | DROPPER, CEPTI-SEAL KOH SOLUTION |
| Classification | Media, Mounting, Water Soluble |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEQ |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-03 |
| Decision Date | 1978-11-22 |