510(k) K883630
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1988
- Date Received
- August 22, 1988
- 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