The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Pump-ject Syringe With Luer-lock.
| Device ID | K894041 |
| 510k Number | K894041 |
| Device Name: | PUMP-JECT SYRINGE WITH LUER-LOCK |
| Classification | Pump, Infusion |
| Applicant | ZIEHM INTERNATIONAL, INC. 1886 SANTA ANITA AVENUE, South El Monte, CA 91733 |
| Contact | Ann L Nadler |
| Correspondent | Ann L Nadler ZIEHM INTERNATIONAL, INC. 1886 SANTA ANITA AVENUE, South El Monte, CA 91733 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-08-28 |