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 |