The following data is part of a premarket notification filed by Dao Health with the FDA for Freemie Breast Collection System.
Device ID | K130349 |
510k Number | K130349 |
Device Name: | FREEMIE BREAST COLLECTION SYSTEM |
Classification | Pump, Breast, Powered |
Applicant | DAO HEALTH 1345 EASY LN. EL DORADO HILLS California, CA 95762 |
Contact | Dan Garbez |
Correspondent | Dan Garbez DAO HEALTH 1345 EASY LN. EL DORADO HILLS California, CA 95762 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-02-12 |
Decision Date | 2013-09-06 |
Summary: | summary |