510(k) K801246

OXFORD HUMAN MILK PASTEURISER by Vickers America Medical Corp. — Product Code HGX

K801246 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "OXFORD HUMAN MILK PASTEURISER". The FDA issued a decision of Substantially Equivalent on October 3, 1980. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1980
Date Received
May 28, 1980
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