510(k) K792095
K792095 is an FDA 510(k) premarket notification submitted by Thermolyne Corp. for the device "HISTO-CENTER II". The FDA issued a decision of Substantially Equivalent on November 20, 1979. The device falls under product code IDW (Dispensers, Paraffin), a Class I device regulated under 21 CFR 864.3010. Thermolyne Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1979
- Date Received
- October 17, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dispensers, Paraffin
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type