510(k) K781043
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 1978
- Date Received
- June 20, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Filter, Membrane
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type