510(k) K812835
Clearance Details
- Decision
- SESP ()
- Decision Date
- October 9, 1981
- Date Received
- October 9, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cresolphthalein Complexone, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type