The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Dvt-2600.
Device ID | K203016 |
510k Number | K203016 |
Device Name: | DVT-2600 |
Classification | Sleeve, Limb, Compressible |
Applicant | Daesung Maref Co., LTD 298-24, Gongdan-Ro Gunpo-si, KR 15809 |
Contact | Su Hyeon So |
Correspondent | Su Hyeon So Daesung Maref Co., LTD 298-24, Gongdan-Ro Gunpo-si, KR 15809 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-01 |
Decision Date | 2020-12-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
18809315675700 | K203016 | 000 |
18809315675359 | K203016 | 000 |
18809315675342 | K203016 | 000 |
18809315675335 | K203016 | 000 |
08809315675307 | K203016 | 000 |
08809315675802 | K203016 | 000 |
08809315675796 | K203016 | 000 |
08809315675789 | K203016 | 000 |
18809315675779 | K203016 | 000 |
18809315675762 | K203016 | 000 |
18809315675755 | K203016 | 000 |
18809315675748 | K203016 | 000 |
18809315675731 | K203016 | 000 |
18809315675724 | K203016 | 000 |
18809315675717 | K203016 | 000 |
18809315675366 | K203016 | 000 |
18809315675373 | K203016 | 000 |
18809315675380 | K203016 | 000 |
18809315675694 | K203016 | 000 |
18809315675540 | K203016 | 000 |
18809315675533 | K203016 | 000 |
18809315675526 | K203016 | 000 |
18809315675519 | K203016 | 000 |
18809315675502 | K203016 | 000 |
18809315675496 | K203016 | 000 |
18809315675489 | K203016 | 000 |
18809315675472 | K203016 | 000 |
18809315675465 | K203016 | 000 |
18809315675458 | K203016 | 000 |
18809315675434 | K203016 | 000 |
18809315675427 | K203016 | 000 |
18809315675397 | K203016 | 000 |
18809802643946 | K203016 | 000 |