The following data is part of a premarket notification filed by Marz Medical, Inc with the FDA for Blossom Saline Delivery Assist Device.
| Device ID | K131692 |
| 510k Number | K131692 |
| Device Name: | BLOSSOM SALINE DELIVERY ASSIST DEVICE |
| Classification | Expander, Skin, Inflatable |
| Applicant | MARZ MEDICAL, INC 2500 HOSPITAL DRIVE BUILDING 9 Mountain View, CA 94040 |
| Contact | Mary Pascual Gallup |
| Correspondent | Mary Pascual Gallup MARZ MEDICAL, INC 2500 HOSPITAL DRIVE BUILDING 9 Mountain View, CA 94040 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2014-07-10 |
| Summary: | summary |