The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Aspach 65,000 (modification).
| Device ID | K955084 |
| 510k Number | K955084 |
| Device Name: | ASPACH 65,000 (MODIFICATION) |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | William E Anspach |
| Correspondent | William E Anspach THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-19 |
| Decision Date | 1996-01-17 |