510(k) K022933
K022933 is an FDA 510(k) premarket notification submitted by Evenflo Company, Inc. for the device "EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT". The FDA issued a decision of Substantially Equivalent on December 2, 2002. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Evenflo Company, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2002
- Date Received
- September 4, 2002
- 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