The following data is part of a premarket notification filed by Linde Gas Therapeutics with the FDA for Linde Integrated Valve (liv).
Device ID | K063354 |
510k Number | K063354 |
Device Name: | LINDE INTEGRATED VALVE (LIV) |
Classification | Cylinder, Compressed Gas, And Valve |
Applicant | LINDE GAS THERAPEUTICS P.O. BOX 470218 Broadview Heights, OH 44147 |
Contact | James J Rogers |
Correspondent | James J Rogers LINDE GAS THERAPEUTICS P.O. BOX 470218 Broadview Heights, OH 44147 |
Product Code | ECX |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-06 |
Decision Date | 2007-04-17 |
Summary: | summary |