The following data is part of a premarket notification filed by .decimal, Llc with the FDA for .decimal P.d.
| Device ID | K151369 |
| 510k Number | K151369 |
| Device Name: | .decimal P.d |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | .DECIMAL, LLC 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Contact | Kevin Erhart |
| Correspondent | Kevin Erhart .DECIMAL, LLC 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851147007069 | K151369 | 000 |