The following data is part of a premarket notification filed by Learning Curve Brands Inc. The First Years with the FDA for Mipump Single Electric/battery Breat Pump & Mipump Double Electric/battery Breast Pump & Mipump Deluxe Double Electric/b.
Device ID | K082802 |
510k Number | K082802 |
Device Name: | MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B |
Classification | Pump, Breast, Powered |
Applicant | LEARNING CURVE BRANDS INC. THE FIRST YEARS 100 TECHNOLOGY CTR. DR. SUITE 2A Stoughton, MA 02072 |
Contact | Supravan Khongkruaphan |
Correspondent | Casey Conroy UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-09-24 |
Decision Date | 2008-10-09 |
Summary: | summary |