The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Shielded Attachment.
| Device ID | K974025 |
| 510k Number | K974025 |
| Device Name: | ANSPACH SHIELDED ATTACHMENT |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | William E Anspach Iii |
| Correspondent | William E Anspach Iii THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-23 |
| Decision Date | 1998-07-06 |