The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Stick-gard Safety Needle.
| Device ID | K890620 |
| 510k Number | K890620 |
| Device Name: | STICK-GARD SAFETY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ZIEHM INTERNATIONAL, INC. 1886 SANTA ANITA AVENUE, South El Monte, CA 91733 |
| Contact | Ann Nadler |
| Correspondent | Ann Nadler ZIEHM INTERNATIONAL, INC. 1886 SANTA ANITA AVENUE, South El Monte, CA 91733 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-07 |
| Decision Date | 1989-02-28 |