The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Bone Screw Nut.
Device ID | K874669 |
510k Number | K874669 |
Device Name: | ACE BONE SCREW NUT |
Classification | Washer, Bolt Nut |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1987-12-11 |