The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Autoband Ligator.
Device ID | K132535 |
510k Number | K132535 |
Device Name: | AUTOBAND LIGATOR |
Classification | Ligator, Esophageal |
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 | MND |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-13 |
Decision Date | 2013-08-23 |
Summary: | summary |