The following data is part of a premarket notification filed by Mediflex Intl. with the FDA for Primary Dressing Tray.
| Device ID | K915140 |
| 510k Number | K915140 |
| Device Name: | PRIMARY DRESSING TRAY |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDIFLEX INTL. 19 BUTTERFIELD TRAIL BLVD. El Paso, TX 79906 |
| Contact | Orlando Cordova |
| Correspondent | Orlando Cordova MEDIFLEX INTL. 19 BUTTERFIELD TRAIL BLVD. El Paso, TX 79906 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-02-11 |