The following data is part of a premarket notification filed by Evenflo Co., Inc. with the FDA for Evenflo Natural Mother Electric Breast Pump Kit.
Device ID | K960727 |
510k Number | K960727 |
Device Name: | EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT |
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 | 1996-02-22 |
Decision Date | 1997-02-14 |