The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Imri Safe Surgical Drill System.
| Device ID | K061297 |
| 510k Number | K061297 |
| Device Name: | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM |
| Classification | Motor, Drill, Pneumatic |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | James Carbone |
| Correspondent | James Carbone 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 | 2006-05-09 |
| Decision Date | 2007-01-26 |
| Summary: | summary |