The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Stratasys Fdm Medmodeler System.
| Device ID | K971290 |
| 510k Number | K971290 |
| Device Name: | STRATASYS FDM MEDMODELER SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-06-20 |
| Summary: | summary |