The following data is part of a premarket notification filed by Simplisse Inc. with the FDA for Simplisse Electric Breastfeeding Companion.
| Device ID | K093648 |
| 510k Number | K093648 |
| Device Name: | SIMPLISSE ELECTRIC BREASTFEEDING COMPANION |
| Classification | Pump, Breast, Powered |
| Applicant | SIMPLISSE INC. 1340 WEST PENNSYLVANIA AVE San Diego, CA 92103 |
| Contact | Glen Feye |
| Correspondent | Glen Feye SIMPLISSE INC. 1340 WEST PENNSYLVANIA AVE San Diego, CA 92103 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2010-07-14 |
| Summary: | summary |