The following data is part of a premarket notification filed by Higa Manufacturing Ltd. with the FDA for H-type Bridge Remover.
| Device ID | K842026 |
| 510k Number | K842026 |
| Device Name: | H-TYPE BRIDGE REMOVER |
| Classification | Remover, Crown |
| Applicant | HIGA MANUFACTURING LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EIS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-18 |
| Decision Date | 1984-07-11 |