The following data is part of a premarket notification filed by Hygeia Medical, Inc. with the FDA for Endeare Breast Pump.
| Device ID | K081932 |
| 510k Number | K081932 |
| Device Name: | ENDEARE BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | HYGEIA MEDICAL, INC. 6353 CORTE DEL ABETO SUITE 102 Carlsbad, CA 92011 |
| Contact | Jasper Benke |
| Correspondent | Jasper Benke HYGEIA MEDICAL, INC. 6353 CORTE DEL ABETO SUITE 102 Carlsbad, CA 92011 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2009-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865278000479 | K081932 | 000 |
| 00865278000462 | K081932 | 000 |
| 00865278000417 | K081932 | 000 |
| 00865278000400 | K081932 | 000 |
| 00860001425277 | K081932 | 000 |
| 00860001425260 | K081932 | 000 |
| 00860001425253 | K081932 | 000 |
| 00860001425246 | K081932 | 000 |
| 00860001425239 | K081932 | 000 |