The following data is part of a premarket notification filed by Southeastern Radiation Products, Inc. with the FDA for Blocking Tray.
| Device ID | K023636 |
| 510k Number | K023636 |
| Device Name: | BLOCKING TRAY |
| Classification | Accelerator, Linear, Medical |
| Applicant | SOUTHEASTERN RADIATION PRODUCTS, INC. 2651 N. DESIGN COURT Sanford, FL 32773 |
| Contact | Richard Sweat |
| Correspondent | Richard Sweat SOUTHEASTERN RADIATION PRODUCTS, INC. 2651 N. DESIGN COURT Sanford, FL 32773 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2002-11-22 |
| Summary: | summary |