510(k) K960727
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)