The following data is part of a premarket notification filed by Martech Medical Products, Inc. with the FDA for Needle Guard(tm).
| Device ID | K890473 |
| 510k Number | K890473 |
| Device Name: | NEEDLE GUARD(TM) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MARTECH MEDICAL PRODUCTS, INC. 7555 JURUPA AVE. SUITE E Riverside, CA 92504 |
| Contact | Michael D Martell |
| Correspondent | Michael D Martell MARTECH MEDICAL PRODUCTS, INC. 7555 JURUPA AVE. SUITE E Riverside, CA 92504 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-31 |
| Decision Date | 1989-04-03 |