The following data is part of a premarket notification filed by 3d Systems, Inc. with the FDA for D2p.
| Device ID | K161841 |
| 510k Number | K161841 |
| Device Name: | D2P |
| Classification | System, Image Processing, Radiological |
| Applicant | 3D SYSTEMS, INC. CORNER OF GOLAN AND HANEGEV STREET Airport City, IL 70151 |
| Contact | Kim Torluemke |
| Correspondent | Kim Torluemke 3D SYSTEMS, INC. 5381 SOUTH ALKIRE CIRCLE Littleton, CO 80127 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2017-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816847021470 | K161841 | 000 |
| 00816847022569 | K161841 | 000 |