The following data is part of a premarket notification filed by .decimal, Inc. with the FDA for Bolus Compensator.
| Device ID | K091911 |
| 510k Number | K091911 |
| Device Name: | BOLUS COMPENSATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Contact | Daniel L Bennett |
| Correspondent | Daniel L Bennett .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-25 |
| Decision Date | 2009-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851147007021 | K091911 | 000 |