510(k) K770792
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 1977
- Date Received
- May 2, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methylene Blue, Tissue Stain
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type