The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for The Bioplate Battery Powered Drill.
| Device ID | K022986 |
| 510k Number | K022986 |
| Device Name: | THE BIOPLATE BATTERY POWERED DRILL |
| Classification | Motor, Drill, Electric |
| Applicant | BIOPLATE, INC. 815 CONNECTICUT AVE NW Washington, DC 20006 -4004 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler BIOPLATE, INC. 815 CONNECTICUT AVE NW Washington, DC 20006 -4004 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-11-19 |
| Summary: | summary |