The following data is part of a premarket notification filed by Jointechlabs, Inc. with the FDA for Jtl-250-01.
Device ID | K182732 |
510k Number | K182732 |
Device Name: | JTL-250-01 |
Classification | System, Suction, Lipoplasty |
Applicant | Jointechlabs, Inc. 8 Graystone Court North Barrington, IL 60010 |
Contact | Thomas Lawson |
Correspondent | Thomas Lawson Jointechlabs, Inc. 8 Graystone Court North Barrington, IL 60010 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-28 |
Decision Date | 2019-11-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860003545232 | K182732 | 000 |