The following data is part of a premarket notification filed by Topslane International, Llc with the FDA for Topslane Dmlc.
| Device ID | K060187 |
| 510k Number | K060187 |
| Device Name: | TOPSLANE DMLC |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | TOPSLANE INTERNATIONAL, LLC 15375 ROOSEVELT BLVD. SUITE # 300 Clearwater, FL 33760 |
| Contact | Jim Marsh |
| Correspondent | Jim Marsh TOPSLANE INTERNATIONAL, LLC 15375 ROOSEVELT BLVD. SUITE # 300 Clearwater, FL 33760 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-24 |
| Decision Date | 2006-07-27 |
| Summary: | summary |