The following data is part of a premarket notification filed by Limerick, Inc. with the FDA for Limerick Pj's Comfort Jr Portable Electric Breast Pump.
Device ID | K051926 |
510k Number | K051926 |
Device Name: | LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP |
Classification | Pump, Breast, Powered |
Applicant | LIMERICK, INC. 1313-23RD ROAD Kanopolis, KS 67454 |
Contact | Paul Krumm |
Correspondent | Paul Krumm LIMERICK, INC. 1313-23RD ROAD Kanopolis, KS 67454 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-18 |
Decision Date | 2005-12-12 |
Summary: | summary |