The following data is part of a premarket notification filed by Devetec, Inc. with the FDA for Polychrome Iv Stain.
| Device ID | K854176 |
| 510k Number | K854176 |
| Device Name: | POLYCHROME IV STAIN |
| Classification | Stains, Chemical Solution |
| Applicant | DEVETEC, INC. P.O. BOX 10275 Bradenton, FL 34282 -0275 |
| Contact | Donald L Price |
| Correspondent | Donald L Price DEVETEC, INC. P.O. BOX 10275 Bradenton, FL 34282 -0275 |
| Product Code | LED |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1985-10-31 |