The following data is part of a premarket notification filed by Numedtec, Inc. with the FDA for Support Ring.
Device ID | K904485 |
510k Number | K904485 |
Device Name: | SUPPORT RING |
Classification | Device, External Penile Rigidity |
Applicant | NUMEDTEC, INC. 29475 HAWTHORNE LN. Libertyville, IL 60048 |
Contact | Peter Miller |
Correspondent | Peter Miller NUMEDTEC, INC. 29475 HAWTHORNE LN. Libertyville, IL 60048 |
Product Code | LKY |
CFR Regulation Number | 876.5020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-02 |
Decision Date | 1990-12-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUPPORT RING 76391852 2863269 Dead/Cancelled |
BRIDGESTONE CORPORATION 2002-04-05 |