The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Xcam.
Device ID | K192700 |
510k Number | K192700 |
Device Name: | Xcam |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | HDX WILL Corp. #105,106,201,202,203,204,38,Osongsaengmyeong-4-ro Osong-eup,Heungdeok-gu Cheongju-si, KR 28161 |
Contact | Myoung-joon Lee |
Correspondent | Myoung-joon Lee HDX WILL Corp. #105,106,201,202,203,204,38,Osongsaengmyeong-4-ro Osong-eup,Heungdeok-gu Cheongju-si, KR 28161 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-26 |
Decision Date | 2019-12-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800005200175 | K192700 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() XCAM 98867292 not registered Live/Pending |
XShaper LLC 2024-11-22 |
![]() XCAM 78301867 3257673 Dead/Cancelled |
X10 Wireless Technology, Inc. 2003-09-17 |
![]() XCAM 74640512 2030900 Dead/Cancelled |
Wiesmann, Donald R. 1995-03-01 |