K911895 is an FDA 510(k) clearance for the QUALTEX SUTURE BOOTIES. This device is classified as a Instrument, Manual, Surgical, General Use (Class I - General Controls, product code MDM).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on May 8, 1991, 9 days after receiving the submission on April 29, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K911895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1991 |
| Decision Date | May 08, 1991 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MDM — Instrument, Manual, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |