The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Bite Block.
Device ID | K954352 |
510k Number | K954352 |
Device Name: | BITE BLOCK |
Classification | Block, Bite |
Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
Contact | Gretchen Younker |
Correspondent | Gretchen Younker UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
Product Code | JXL |
CFR Regulation Number | 882.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-18 |
Decision Date | 1996-01-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BITE BLOCK 97079671 not registered Live/Pending |
Keen Products Inc. 2021-10-18 |
BITE BLOCK 90779029 not registered Live/Pending |
Keen Products Inc. 2021-06-17 |
BITE BLOCK 75200107 not registered Dead/Abandoned |
National hearing Aid Distributors, Inc. 1996-11-19 |
BITE BLOCK 75085590 2093688 Dead/Cancelled |
SUN PHARMACEUTICALS CORP. 1996-04-09 |