510(k) K935763
K935763 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine GmbH for the device "SURGIPUMP". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. W.O.M. World of Medicine GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1994
- Date Received
- November 26, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Withdrawal/Infusion Pump
- Device Class
- Class II
- Regulation Number
- 870.1800
- Review Panel
- HO
- Submission Type