The following data is part of a premarket notification filed by Shangdong Zibo Shanchuan Medical Instruments Co. with the FDA for Shanchuan Syringe.
| Device ID | K021993 |
| 510k Number | K021993 |
| Device Name: | SHANCHUAN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. 12951 BRIAR FOREST DRIVE # 303 Houston, TX 77077 |
| Contact | Hairong Che |
| Correspondent | Hairong Che SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. 12951 BRIAR FOREST DRIVE # 303 Houston, TX 77077 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2003-06-03 |
| Summary: | summary |