The following data is part of a premarket notification filed by Symcare Personalized Health Solutions, Inc with the FDA for Intouch Diabetes.
Device ID | K093789 |
510k Number | K093789 |
Device Name: | INTOUCH DIABETES |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC 965 CHESTERBROOK BLVD Wayne, PA 19087 |
Contact | Rae Ann Delay |
Correspondent | Rae Ann Delay SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC 965 CHESTERBROOK BLVD Wayne, PA 19087 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-09 |
Decision Date | 2010-02-19 |
Summary: | summary |