The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Surgical Irrigation System, Irrigation Tube.
| Device ID | K063688 |
| 510k Number | K063688 |
| Device Name: | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jim Banic |
| Correspondent | Jim Banic THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-12 |
| Decision Date | 2007-01-16 |
| Summary: | summary |