The following data is part of a premarket notification filed by Liger Medical, Llc with the FDA for Liger Medical Htu-110.
Device ID | K152843 |
510k Number | K152843 |
Device Name: | Liger Medical HTU-110 |
Classification | Electrocautery, Gynecologic (and Accessories) |
Applicant | LIGER MEDICAL, LLC 14062 S RUNNING CREEK WAY Draper, UT 84020 |
Contact | Steve Smith |
Correspondent | Steve Smith LIGER MEDICAL, LLC 14062 S RUNNING CREEK WAY Draper, UT 84020 |
Product Code | HGI |
CFR Regulation Number | 884.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-29 |
Decision Date | 2016-06-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861592000355 | K152843 | 000 |
00861592000348 | K152843 | 000 |
00861592000331 | K152843 | 000 |
00861592000324 | K152843 | 000 |