510(k) K801246
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