The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Hdl-cholesterol Precipitant 7773/7573/7473/7173.
| Device ID | K905284 |
| 510k Number | K905284 |
| Device Name: | HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Praful Patel |
| Correspondent | Praful Patel AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-23 |
| Decision Date | 1990-12-11 |