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 |