The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for The Venous Assist System.
Device ID | K112677 |
510k Number | K112677 |
Device Name: | THE VENOUS ASSIST SYSTEM |
Classification | Sleeve, Limb, Compressible |
Applicant | DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles, CA 90004 |
Contact | Daniel Nam |
Correspondent | Daniel Nam DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles, CA 90004 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-14 |
Decision Date | 2012-01-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
28809315678395 | K112677 | 000 |
38809315678613 | K112677 | 000 |
38809315678590 | K112677 | 000 |
38809315678576 | K112677 | 000 |
38809315678538 | K112677 | 000 |
08809315678513 | K112677 | 000 |
38809315678477 | K112677 | 000 |
38809315678453 | K112677 | 000 |
38809315678439 | K112677 | 000 |
08809315678414 | K112677 | 000 |
38809315678637 | K112677 | 000 |
38809315678699 | K112677 | 000 |
38809315678736 | K112677 | 000 |
38809315678835 | K112677 | 000 |
08809315678490 | K112677 | 000 |
38809315678811 | K112677 | 000 |
38809315678774 | K112677 | 000 |
38809315678712 | K112677 | 000 |
38809315678651 | K112677 | 000 |
38809315678910 | K112677 | 000 |
38809315678798 | K112677 | 000 |
38809315678750 | K112677 | 000 |
08809315678384 | K112677 | 000 |