The following data is part of a premarket notification filed by Endovations with the FDA for Inject-snare.
Device ID | K942110 |
510k Number | K942110 |
Device Name: | INJECT-SNARE |
Classification | Snare, Flexible |
Applicant | ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 Reading, PA 19610 |
Contact | Ronald D Wolfe |
Correspondent | Ronald D Wolfe ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 Reading, PA 19610 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-02 |
Decision Date | 1994-10-13 |