K915430 is an FDA 510(k) clearance for the SKIN STAPLE REMOVER KIT. This device is classified as a Staple, Removable (skin) (Class I - General Controls, product code GDT).
Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on February 28, 1992, 88 days after receiving the submission on December 2, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4760.
| 510(k) Number | K915430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | December 02, 1991 |
| Decision Date | February 28, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDT — Staple, Removable (skin) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4760 |