510(k) K844297

SUPPLEMENTAL FEEDING SYSTEM by Medela, Inc. — Product Code HGY

K844297 is an FDA 510(k) premarket notification submitted by Medela, Inc. for the device "SUPPLEMENTAL FEEDING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Medela, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
October 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type