The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Radiology-diagnostic Kits.
| Device ID | K962826 |
| 510k Number | K962826 |
| Device Name: | MEDLINE RADIOLOGY-DIAGNOSTIC KITS |
| Classification | General Surgery Tray |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara Simmons |
| Correspondent | Lara Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-19 |
| Decision Date | 1996-09-16 |