The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Endoplus.
Device ID | K941969 |
510k Number | K941969 |
Device Name: | ENDOPLUS |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor, MY 43900 |
Contact | Ong Ghee Chee |
Correspondent | Ong Ghee Chee WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor, MY 43900 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-22 |
Decision Date | 1994-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOPLUS 76525763 2847394 Live/Registered |
JSTONE, INC. 2003-06-26 |
ENDOPLUS 74316524 1854089 Dead/Cancelled |
Endoplus Inc. 1992-09-23 |
ENDOPLUS 73604953 1430211 Dead/Cancelled |
DENTSPLY INTERNATIONAL INC. 1986-06-19 |