510(k) K842053
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1984
- Date Received
- May 22, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Formulations, Paraffin, All
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type