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 |