The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Pin Screw.
Device ID | K061599 |
510k Number | K061599 |
Device Name: | PIN SCREW |
Classification | Pin, Fixation, Threaded |
Applicant | BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN Hwasung-si, Kyunggi-do, KR |
Contact | Byungjun Park |
Correspondent | Byungjun Park BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN Hwasung-si, Kyunggi-do, KR |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-08 |
Decision Date | 2006-07-26 |
Summary: | summary |