The following data is part of a premarket notification filed by Innovative Medical Manufacturing Co. with the FDA for Infusion Syringe Set.
| Device ID | K131661 |
| 510k Number | K131661 |
| Device Name: | INFUSION SYRINGE SET |
| Classification | Syringe, Piston |
| Applicant | INNOVATIVE MEDICAL MANUFACTURING CO. 107, LANE 181, SEC. 1 YONG JANE ROAD Chunan, Miaoli, TW 350 |
| Contact | Lucy Huang |
| Correspondent | Lucy Huang INNOVATIVE MEDICAL MANUFACTURING CO. 107, LANE 181, SEC. 1 YONG JANE ROAD Chunan, Miaoli, TW 350 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-07 |
| Decision Date | 2013-11-05 |
| Summary: | summary |