The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Universal Bite Block.
| Device ID | K960663 |
| 510k Number | K960663 |
| Device Name: | UNIVERSAL BITE BLOCK |
| Classification | Block, Bite |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Contact | John D Calebaugh Rrt,rcp |
| Correspondent | John D Calebaugh Rrt,rcp B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-16 |
| Decision Date | 1996-05-17 |