The following data is part of a premarket notification filed by Apk Technology with the FDA for Kits And Trays For One Time Use Only.
| Device ID | K903963 |
| 510k Number | K903963 |
| Device Name: | KITS AND TRAYS FOR ONE TIME USE ONLY |
| Classification | Tray, Surgical |
| Applicant | APK TECHNOLOGY POB 6462 GANEI YEHUDA Israel, IL 56905 |
| Contact | Amir Porat |
| Correspondent | Amir Porat APK TECHNOLOGY POB 6462 GANEI YEHUDA Israel, IL 56905 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1991-07-29 |