510(k) K771625
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1977
- Date Received
- August 25, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instruments, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type