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 |