The following data is part of a premarket notification filed by Shandon, Inc. with the FDA for Instant Eosin-aqueous.
| Device ID | K893663 |
| 510k Number | K893663 |
| Device Name: | INSTANT EOSIN-AQUEOUS |
| Classification | Eosin Y |
| Applicant | SHANDON, INC. 171 INDUSTRY DR. Pittsburgh, PA 15275 |
| Contact | Janet Crookham |
| Correspondent | Janet Crookham SHANDON, INC. 171 INDUSTRY DR. Pittsburgh, PA 15275 |
| Product Code | HYB |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-06-13 |