510(k) K960727

EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT by Evenflo Co., Inc. — Product Code HGX

K960727 is an FDA 510(k) premarket notification submitted by Evenflo Co., Inc. for the device "EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT". The FDA issued a decision of Substantially Equivalent on Feb 14, 1997. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Evenflo Co., Inc. has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 14, 1997
Date Received
Feb 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type
510(k)

Source: FDA 510(k) database entry for K960727. Report a data issue: hello@regdatalab.com.