The following data is part of a premarket notification filed by Esa, Inc. with the FDA for Model 5500 Ceas.
| Device ID | K934977 |
| 510k Number | K934977 |
| Device Name: | MODEL 5500 CEAS |
| Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
| Applicant | ESA, INC. 45 WIGGINS AVE. Bedford, MA 01730 |
| Contact | James Mayol |
| Correspondent | James Mayol ESA, INC. 45 WIGGINS AVE. Bedford, MA 01730 |
| Product Code | CDF |
| CFR Regulation Number | 862.1795 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-19 |
| Decision Date | 1994-01-11 |