The following data is part of a premarket notification filed by Moerae Matrix, Inc. with the FDA for Moerae Vein Preparation Kit.
| Device ID | K131659 |
| 510k Number | K131659 |
| Device Name: | MOERAE VEIN PREPARATION KIT |
| Classification | Catheter, Irrigation |
| Applicant | MOERAE MATRIX, INC. 25 HARTFORD AVENUE San Carlos, CA 94070 |
| Contact | Robert J Chin |
| Correspondent | Robert J Chin MOERAE MATRIX, INC. 25 HARTFORD AVENUE San Carlos, CA 94070 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2014-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002037813 | K131659 | 000 |