The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Levtech Small Bone Plate.
Device ID | K893928 |
510k Number | K893928 |
Device Name: | LEVTECH SMALL BONE PLATE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | Bromm, R.n. |
Correspondent | Bromm, R.n. BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | KTW |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-31 |
Decision Date | 1989-11-03 |