The following data is part of a premarket notification filed by Sicel Technologies, Inc. with the FDA for Modification To Onedose Patient Dosimetry System.
| Device ID | K081859 |
| 510k Number | K081859 |
| Device Name: | MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Contact | Suzanne Schwaller |
| Correspondent | Suzanne Schwaller SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-01 |
| Decision Date | 2008-08-04 |
| Summary: | summary |