510(k) K811797
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1981
- Date Received
- June 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eosin Y
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type