The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Implant V1.2.
| Device ID | K103723 |
| 510k Number | K103723 |
| Device Name: | SICAT IMPLANT V1.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | SICAT GMBH & CO. KG 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mark W Sheehan |
| Correspondent | Mark W Sheehan SICAT GMBH & CO. KG 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-21 |
| Decision Date | 2011-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776IMPLANTV15 | K103723 | 000 |
| D776IMPLANTV150 | K103723 | 000 |