510(k) K770720
K770720 is an FDA 510(k) premarket notification submitted by William Harvey Life Products Corp. for the device "TUBING PACK, EXTRACORPOREAL, H-3000". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code BYS (Oxygenator, Long Term Support Greater Than 6 Hours), a Class II device regulated under 21 CFR 870.4100. William Harvey Life Products Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1977
- Date Received
- April 18, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Long Term Support Greater Than 6 Hours
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type