The following data is part of a premarket notification filed by Manamed, Inc with the FDA for Manaflow.
Device ID | K200353 |
510k Number | K200353 |
Device Name: | ManaFlow |
Classification | Sleeve, Limb, Compressible |
Applicant | ManaMed, Inc 5240 W. Charleston Blvd Las Vegas, NV 89146 |
Contact | Trevor Theriot |
Correspondent | Bill Quanqin Dai JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-13 |
Decision Date | 2020-08-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850998008287 | K200353 | 000 |
00850998008270 | K200353 | 000 |
00850998008898 | K200353 | 000 |
00810113682259 | K200353 | 000 |
00810113681511 | K200353 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MANAFLOW 90527646 not registered Live/Pending |
Monospace Protocols LLC 2021-02-12 |
MANAFLOW 90052051 not registered Live/Pending |
MANAMED INC 2020-07-14 |