The following data is part of a premarket notification filed by Symbios Medical Products, Llc with the FDA for Modification To Disposable Infusion Pump Kit.
| Device ID | K071735 |
| 510k Number | K071735 |
| Device Name: | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD., SUITE 150 Indianapolis, IN 46268 |
| Contact | Michael James |
| Correspondent | Michael James SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD., SUITE 150 Indianapolis, IN 46268 |
| 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 | 2007-06-26 |
| Decision Date | 2007-07-19 |
| Summary: | summary |