510(k) K810320
K810320 is an FDA 510(k) premarket notification submitted by Shinsei Corp. for the device "HEATPAC". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code IMB (Cabinet, Moist Steam), a Class II device regulated under 21 CFR 890.5250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1981
- Date Received
- February 6, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Moist Steam
- Device Class
- Class II
- Regulation Number
- 890.5250
- Review Panel
- PM
- Submission Type