The following data is part of a premarket notification filed by Evenflo Co., Inc. with the FDA for Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump.
Device ID | K983776 |
510k Number | K983776 |
Device Name: | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP |
Classification | Pump, Breast, Powered |
Applicant | EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
Contact | Donald E Segal |
Correspondent | Donald E Segal EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-26 |
Decision Date | 1999-04-26 |
Summary: | summary |