K911204 is an FDA 510(k) clearance for the QUALTEX SKIN STAPLE EXTRACTOR. This device is classified as a Staple, Removable (skin) (Class I - General Controls, product code GDT).
Submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on May 8, 1991, 50 days after receiving the submission on March 19, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4760.
| 510(k) Number | K911204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1991 |
| Decision Date | May 08, 1991 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDT — Staple, Removable (skin) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4760 |