The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Wedjets.
| Device ID | K900844 |
| 510k Number | K900844 |
| Device Name: | WEDJETS |
| Classification | Dam, Rubber |
| 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 | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-04-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WEDJETS 74033109 1658658 Live/Registered |
HYGENIC CORPORATION, THE 1990-02-21 |