The following data is part of a premarket notification filed by Moller Medical Gmbh with the FDA for Liquoguard 7, Liquoguard 7 Drainage Set, Lenght 2000mm.
Device ID | K150898 |
510k Number | K150898 |
Device Name: | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm |
Classification | Shunt, Central Nervous System And Components |
Applicant | MOLLER MEDICAL GMBH WASSERKUPPENSTR.29-31 Fulda, DE 36043 |
Contact | Juliane Dragon |
Correspondent | Juliane Dragon MOLLER MEDICAL GMBH WASSERKUPPENSTR.29-31 Fulda, DE 36043 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-02 |
Decision Date | 2015-12-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260277176167 | K150898 | 000 |
04260277176136 | K150898 | 000 |
04260277176105 | K150898 | 000 |
04260277176075 | K150898 | 000 |
04260277176020 | K150898 | 000 |
04260277175788 | K150898 | 000 |