The following data is part of a premarket notification filed by Brasseler Usa I, L.p. with the FDA for Small High Speed Motor Drill System.
| Device ID | K030172 |
| 510k Number | K030172 |
| Device Name: | SMALL HIGH SPEED MOTOR DRILL SYSTEM |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | BRASSELER USA I, L.P. 4837 MCGRATH ST., SUITE J Ventura, CA 93003 |
| Contact | Anthony V Rose |
| Correspondent | Anthony V Rose BRASSELER USA I, L.P. 4837 MCGRATH ST., SUITE J Ventura, CA 93003 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-17 |
| Decision Date | 2003-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887919710295 | K030172 | 000 |
| 00887919458845 | K030172 | 000 |
| 00887919459033 | K030172 | 000 |
| 00887919496953 | K030172 | 000 |
| 00887919497103 | K030172 | 000 |
| 00887919497189 | K030172 | 000 |
| 00887919497271 | K030172 | 000 |
| 00887919497363 | K030172 | 000 |
| 00887919497431 | K030172 | 000 |
| 00887919497523 | K030172 | 000 |
| 00887919497615 | K030172 | 000 |
| 00887919497707 | K030172 | 000 |
| 00887919497783 | K030172 | 000 |
| 00887919499398 | K030172 | 000 |
| 00887919502821 | K030172 | 000 |
| 00887919502890 | K030172 | 000 |
| 00887919510376 | K030172 | 000 |
| 00887919458685 | K030172 | 000 |