The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Endosheath.
Device ID | K925421 |
510k Number | K925421 |
Device Name: | ENDOSHEATH |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
Contact | Alan I West |
Correspondent | Alan I West VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-27 |
Decision Date | 1993-01-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOSHEATH 86539305 5015565 Live/Registered |
COGENTIX MEDICAL, INC. 2015-02-19 |
ENDOSHEATH 86490133 not registered Dead/Abandoned |
Encision, Inc. 2014-12-24 |
ENDOSHEATH 74706949 2002713 Live/Registered |
COGENTIX MEDICAL, INC. 1995-07-27 |
ENDOSHEATH 74427279 1849840 Dead/Cancelled |
COGENTIX MEDICAL, INC. 1993-08-23 |