510(k) K812617
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1981
- Date Received
- September 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media And Components, Synthetic Cell And Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2220
- Review Panel
- PA
- Submission Type