The following data is part of a premarket notification filed by Plastic Engineered Products Co. with the FDA for Jaw Blocker.
| Device ID | K896745 |
| 510k Number | K896745 |
| Device Name: | JAW BLOCKER |
| Classification | Block, Bite |
| Applicant | PLASTIC ENGINEERED PRODUCTS CO. 800 SAVANNAH AVENUE N.E. Canton, OH 44704 |
| Contact | P Thompson |
| Correspondent | P Thompson PLASTIC ENGINEERED PRODUCTS CO. 800 SAVANNAH AVENUE N.E. Canton, OH 44704 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1989-12-14 |