The following data is part of a premarket notification filed by Moller Medical Gmbh with the FDA for Liquoguard Csf Liquoguard Csf Tubing Set (1500mm) Liquoguard Csf Tubing Set (2000mm) Safety Cushion For Tubing Set Attac.
Device ID | K121248 |
510k Number | K121248 |
Device Name: | LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC |
Classification | Shunt, Central Nervous System And Components |
Applicant | MOLLER MEDICAL GMBH 1612 JENKS DRIVE Corona, CA 92880 |
Contact | Grant Geckeler |
Correspondent | Grant Geckeler MOLLER MEDICAL GMBH 1612 JENKS DRIVE Corona, CA 92880 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-25 |
Decision Date | 2013-12-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260277175986 | K121248 | 000 |
04260277175955 | K121248 | 000 |
04260277170011 | K121248 | 000 |