The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Helix Dissection Tools.
| Device ID | K183545 |
| 510k Number | K183545 |
| Device Name: | Anspach Helix Dissection Tools |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Tamara J. West |
| Correspondent | Tamara J. West The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845384018247 | K183545 | 000 |
| 00845384017967 | K183545 | 000 |
| 00845384017905 | K183545 | 000 |
| 00845384017899 | K183545 | 000 |
| 00845384017882 | K183545 | 000 |
| 00845384017875 | K183545 | 000 |
| 00845384017868 | K183545 | 000 |
| 00845384017851 | K183545 | 000 |
| 00845384017844 | K183545 | 000 |
| 00845384017837 | K183545 | 000 |
| 00845384017820 | K183545 | 000 |
| 00845384017813 | K183545 | 000 |
| 00845384017806 | K183545 | 000 |
| 00845384017974 | K183545 | 000 |
| 00845384018001 | K183545 | 000 |
| 00845384018230 | K183545 | 000 |
| 00845384018223 | K183545 | 000 |
| 00845384018216 | K183545 | 000 |
| 00845384018186 | K183545 | 000 |
| 00845384018179 | K183545 | 000 |
| 00845384018148 | K183545 | 000 |
| 00845384018131 | K183545 | 000 |
| 00845384018070 | K183545 | 000 |
| 00845384018063 | K183545 | 000 |
| 00845384018056 | K183545 | 000 |
| 00845384018049 | K183545 | 000 |
| 00845384018018 | K183545 | 000 |
| 00845384017790 | K183545 | 000 |