The following data is part of a premarket notification filed by Symbios Medical Products, Llc with the FDA for Disposable Infusion Pump Kit, Go Pump Rapid Recovery System.
Device ID | K072921 |
510k Number | K072921 |
Device Name: | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM |
Classification | Pump, Infusion, Elastomeric |
Applicant | SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD SUITE 150 Indianapolis, IN 46268 -4194 |
Contact | Jeffrey Alholm |
Correspondent | Jeffrey Alholm SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD SUITE 150 Indianapolis, IN 46268 -4194 |
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 | 2007-10-15 |
Decision Date | 2007-11-26 |