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 |