The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Powered Kerrison System (pks).
| Device ID | K022907 |
| 510k Number | K022907 |
| Device Name: | ANSPACH POWERED KERRISON SYSTEM (PKS) |
| Classification | Rongeur, Powered |
| 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 | HAD |
| CFR Regulation Number | 882.4845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2002-10-21 |
| Summary: | summary |