The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Acromed Interbody Depth Gauges.
Device ID | K873191 |
510k Number | K873191 |
Device Name: | ACROMED INTERBODY DEPTH GAUGES |
Classification | Gauge, Depth |
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 | HTJ |
CFR Regulation Number | 888.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-13 |
Decision Date | 1987-09-09 |