The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Brooker Bone Plating System.
Device ID | K833865 |
510k Number | K833865 |
Device Name: | ACE BROOKER BONE PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | BUCKMAN CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-07 |
Decision Date | 1983-12-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887868077197 | K833865 | 000 |
00887868006135 | K833865 | 000 |
00887868006128 | K833865 | 000 |
00887868006111 | K833865 | 000 |
00887868006098 | K833865 | 000 |
00887868006081 | K833865 | 000 |
00887868009990 | K833865 | 000 |
00887868009815 | K833865 | 000 |
00887868006074 | K833865 | 000 |
00887868006067 | K833865 | 000 |
00887868006050 | K833865 | 000 |
00887868006043 | K833865 | 000 |
00887868006036 | K833865 | 000 |
00887868006029 | K833865 | 000 |
00887868004667 | K833865 | 000 |
00887868004650 | K833865 | 000 |
00887868004643 | K833865 | 000 |
00887868006142 | K833865 | 000 |
00887868006159 | K833865 | 000 |
00887868006166 | K833865 | 000 |
00887868006326 | K833865 | 000 |
00887868006319 | K833865 | 000 |
00887868006302 | K833865 | 000 |
00887868006296 | K833865 | 000 |
00887868006289 | K833865 | 000 |
00887868006272 | K833865 | 000 |
00887868006265 | K833865 | 000 |
00887868006258 | K833865 | 000 |
00887868006241 | K833865 | 000 |
00887868006234 | K833865 | 000 |
00887868006227 | K833865 | 000 |
00887868006210 | K833865 | 000 |
00887868006203 | K833865 | 000 |
00887868006197 | K833865 | 000 |
00887868006180 | K833865 | 000 |
00887868006173 | K833865 | 000 |
00887868004636 | K833865 | 000 |