The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Bone Plate System.
Device ID | K942359 |
510k Number | K942359 |
Device Name: | BONE PLATE SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Contact | Shari Jeffers |
Correspondent | Shari Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-17 |
Decision Date | 1995-04-13 |