K974025 is an FDA 510(k) clearance for the ANSPACH SHIELDED ATTACHMENT. This device is classified as a Bur, Surgical, General & Plastic Surgery (Class I - General Controls, product code GFF).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 6, 1998, 256 days after receiving the submission on October 23, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K974025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1997 |
| Decision Date | July 06, 1998 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GFF — Bur, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |