The following data is part of a premarket notification filed by Whittlestone, Inc. with the FDA for Dr Brown's Natural Flow Double Electric Breast Pump, Model# 1400.
Device ID | K070435 |
510k Number | K070435 |
Device Name: | DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 |
Classification | Pump, Breast, Powered |
Applicant | WHITTLESTONE, INC. 102 HERITAGE AVE Castle Rock, CO 80104 -y |
Contact | Glen Thibault |
Correspondent | Glen Thibault WHITTLESTONE, INC. 102 HERITAGE AVE Castle Rock, CO 80104 -y |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-15 |
Decision Date | 2007-07-17 |