The following data is part of a premarket notification filed by Spectrum Medical Supply, Inc. with the FDA for Sms Glucose Control, Model 2120061.
Device ID | K070649 |
510k Number | K070649 |
Device Name: | SMS GLUCOSE CONTROL, MODEL 2120061 |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | SPECTRUM MEDICAL SUPPLY, INC. 940 CROSSROADS BLVD Seguin, TX 78155 |
Contact | John C Gormley |
Correspondent | John C Gormley SPECTRUM MEDICAL SUPPLY, INC. 940 CROSSROADS BLVD Seguin, TX 78155 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-08 |
Decision Date | 2007-04-12 |
Summary: | summary |