The following data is part of a premarket notification filed by Solohill Engineering, Inc. with the FDA for Bioglas Microcarrier Bead.
| Device ID | K852506 |
| 510k Number | K852506 |
| Device Name: | BIOGLAS MICROCARRIER BEAD |
| Classification | Apparatus, Roller |
| Applicant | SOLOHILL ENGINEERING, INC. 323 E. WILLIAM, SUITE 44 Ann Arbor, MI 48104 |
| Contact | William J Hillegas |
| Correspondent | William J Hillegas SOLOHILL ENGINEERING, INC. 323 E. WILLIAM, SUITE 44 Ann Arbor, MI 48104 |
| Product Code | KJB |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1985-07-12 |