The following data is part of a premarket notification filed by Sicel Technologies, Inc. with the FDA for Dose Verification System Patient Dosimetry System.
| Device ID | K080004 |
| 510k Number | K080004 |
| Device Name: | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM |
| Classification | Dosimeter, Ionizing Radiation, Implanted |
| Applicant | SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Contact | Tammy B Carrea |
| Correspondent | Tammy B Carrea SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Product Code | NZT |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-02 |
| Decision Date | 2008-01-23 |
| Summary: | summary |