510(k) K830582
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1983
- Date Received
- February 23, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Formalin, Neutral Buffered
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type