The following data is part of a premarket notification filed by Polymedica Pharmaceuticals, U.s.a., Inc.] with the FDA for Liberty Blood Glucose Monitoring System.
| Device ID | K014167 |
| 510k Number | K014167 |
| Device Name: | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] 11 STATE ST. Woburn, MA 01801 |
| Contact | Patricia Collins |
| Correspondent | Patricia Collins POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] 11 STATE ST. Woburn, MA 01801 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-02-19 |
| Summary: | summary |