The following data is part of a premarket notification filed by Symbios Medical Products, Llc with the FDA for Symbios Disposable Infusion Pump Kit.
| Device ID | K051474 |
| 510k Number | K051474 |
| Device Name: | SYMBIOS DISPOSABLE INFUSION PUMP KIT |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | SYMBIOS MEDICAL PRODUCTS, LLC 6131 WEST 80TH STREET Indianapolis, IN 46278 -1344 |
| Contact | Jeffery J Alholm |
| Correspondent | Jeffery J Alholm SYMBIOS MEDICAL PRODUCTS, LLC 6131 WEST 80TH STREET Indianapolis, IN 46278 -1344 |
| Product Code | MEB |
| Subsequent Product Code | BSO |
| Subsequent Product Code | KGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-03 |
| Decision Date | 2005-07-01 |
| Summary: | summary |