The following data is part of a premarket notification filed by .decimal, Inc. with the FDA for .decimal Proton Aperture.
| Device ID | K132236 |
| 510k Number | K132236 |
| Device Name: | .DECIMAL PROTON APERTURE |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Contact | Kimberly Rupp |
| Correspondent | Kimberly Rupp .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2013-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851147007083 | K132236 | 000 |
| 00851147007007 | K132236 | 000 |