K972918 is an FDA 510(k) clearance for the RAPID FIRE HAIR IMPLANTER CAROUSEL. This device is classified as a Stylet, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAH).
Submitted by Apex Medical Products, LLC (Potomac, US). The FDA issued a Cleared decision on October 27, 1997, 81 days after receiving the submission on August 7, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K972918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1997 |
| Decision Date | October 27, 1997 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAH — Stylet, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |