510(k) K860263
K860263 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "CASTLE 7538 FLOOR LOADING WASHER". The FDA issued a decision of Substantially Equivalent on March 5, 1986. The device falls under product code LDS (Device, Pasteurization, Hot Water), a Class II device regulated under 21 CFR 880.6991. Castle Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1986
- Date Received
- January 27, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Pasteurization, Hot Water
- Device Class
- Class II
- Regulation Number
- 880.6991
- Review Panel
- HO
- Submission Type