The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Irrigation Tray.
| Device ID | K900148 |
| 510k Number | K900148 |
| Device Name: | KIT PAK IRRIGATION TRAY |
| Classification | Tray, Irrigation, Sterile |
| Applicant | KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Contact | Thomas J Sanders |
| Correspondent | Thomas J Sanders KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Product Code | EYN |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-11 |
| Decision Date | 1990-04-23 |