The following data is part of a premarket notification filed by Animas Corp. with the FDA for Symphony Glucose Management System.
Device ID | K080639 |
510k Number | K080639 |
Device Name: | SYMPHONY GLUCOSE MANAGEMENT SYSTEM |
Classification | Pump, Infusion, Insulin |
Applicant | ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
Contact | Amy Smith |
Correspondent | Amy Smith ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
Product Code | LZG |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-06 |
Decision Date | 2008-06-24 |
Summary: | summary |