The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Admission Kits.
| Device ID | K965107 |
| 510k Number | K965107 |
| Device Name: | MEDLINE ADMISSION KITS |
| Classification | Mask, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Christine Galea |
| Correspondent | Christine Galea MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-20 |
| Decision Date | 1997-03-11 |
| Summary: | summary |