The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Mri Safe Surgical Drill System.
| Device ID | K040186 |
| 510k Number | K040186 |
| Device Name: | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM |
| Classification | Motor, Drill, Pneumatic |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | William G Conety |
| Correspondent | William G Conety THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-27 |
| Decision Date | 2004-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845384011194 | K040186 | 000 |
| 00845384002680 | K040186 | 000 |
| 00845384002673 | K040186 | 000 |
| 00845384002659 | K040186 | 000 |
| 00845384002642 | K040186 | 000 |
| 00845384002635 | K040186 | 000 |
| 00845384002628 | K040186 | 000 |
| 00845384002574 | K040186 | 000 |