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 |