The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Esa Leadcare Ii Lead Control.
| Device ID | K063398 |
| 510k Number | K063398 |
| Device Name: | ESA LEADCARE II LEAD CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Contact | Randy Byrd |
| Correspondent | Randy Byrd BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01434 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2006-12-05 |
| Summary: | summary |