The following data is part of a premarket notification filed by Pro. Duct Health, Inc. with the FDA for Pro.duct Health Micro-stylet, Model Sty01.
| Device ID | K001098 |
| 510k Number | K001098 |
| Device Name: | PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | PRO. DUCT HEALTH, INC. 1360 WILLOW ROAD, SUITE 201 Menlo Park, CA 94025 |
| Contact | Angela B Soito |
| Correspondent | Angela B Soito PRO. DUCT HEALTH, INC. 1360 WILLOW ROAD, SUITE 201 Menlo Park, CA 94025 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-05-18 |