The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Endocater.
Device ID | K863393 |
510k Number | K863393 |
Device Name: | ENDOCATER |
Classification | Locator, Root Apex |
Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
Contact | T. N Meyer |
Correspondent | T. N Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
Product Code | LQY |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-03 |
Decision Date | 1987-06-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOCATER 73665816 1474851 Dead/Cancelled |
HYGENIC CORPORATION, THE 1987-06-11 |