The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Warsaw Orthopedic Bone Plate.
| Device ID | K862254 |
| 510k Number | K862254 |
| Device Name: | WARSAW ORTHOPEDIC BONE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | WARSAW ORTHOPEDIC, INC. PAMELA M. BUCKMAN 921 CALLE VERDE Martinez, CA 94553 |
| Contact | Buckman Co.,inc. |
| Correspondent | Buckman Co.,inc. WARSAW ORTHOPEDIC, INC. PAMELA M. BUCKMAN 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-13 |
| Decision Date | 1986-07-08 |