The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Smartstart Air/water And Suction Valves.
Device ID | K160403 |
510k Number | K160403 |
Device Name: | SmartStart Air/Water And Suction Valves |
Classification | Endoscope Channel Accessory |
Applicant | ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta, GA 30009 |
Contact | Daniel Hoefer |
Correspondent | Daniel Hoefer ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta, GA 30009 |
Product Code | ODC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-12 |
Decision Date | 2016-05-19 |
Summary: | summary |