510(k) K761050
K761050 is an FDA 510(k) premarket notification submitted by Dws, Inc. for the device "HEPARIN PUMP". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code FIR (Pump, Blood, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Dws, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1976
- Date Received
- November 15, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Extra-Luminal
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type