The following data is part of a premarket notification filed by Essex Industries, Inc. with the FDA for Mr Conditional Cga 870.
Device ID | K162811 |
510k Number | K162811 |
Device Name: | MR Conditional CGA 870 |
Classification | Regulator, Pressure, Gas Cylinder |
Applicant | Essex Industries, Inc. 7700 Gravois St. Louis, MO 63123 |
Contact | Russ Jacobsmeyer |
Correspondent | Paul Dryden Essex Industries, Inc. 7700 Gravois St. Louis, MO 63123 |
Product Code | CAN |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-06 |
Decision Date | 2017-03-02 |
Summary: | summary |