K965107 is an FDA 510(k) clearance for the MEDLINE ADMISSION KITS. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 11, 1997, 81 days after receiving the submission on December 20, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K965107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1996 |
| Decision Date | March 11, 1997 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |