The following data is part of a premarket notification filed by .decimal, Inc. with the FDA for .decimal Aperture.
| Device ID | K071077 |
| 510k Number | K071077 |
| Device Name: | .DECIMAL APERTURE |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Contact | Daniel Bennett |
| Correspondent | Daniel Bennett .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 | 2007-04-17 |
| Decision Date | 2007-05-18 |
| Summary: | summary |