K904172 is an FDA 510(k) clearance for the ACCUPLACE (TM). This device is classified as a Guide, Needle, Surgical (Class I - General Controls, product code GDF).
Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 21, 1990, 71 days after receiving the submission on September 11, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K904172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1990 |
| Decision Date | November 21, 1990 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |