The following data is part of a premarket notification filed by Medpac with the FDA for Hawaiian Supracondylar Plate.
| Device ID | K903697 |
| 510k Number | K903697 |
| Device Name: | HAWAIIAN SUPRACONDYLAR PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDPAC 25768 PARADA DR. Valencia, CA 91355 |
| Contact | David Medoff |
| Correspondent | David Medoff MEDPAC 25768 PARADA DR. Valencia, CA 91355 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-15 |
| Decision Date | 1991-01-15 |