510(k) K844089
K844089 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "CASTLE 7515 UTENSIL/GLASSWARE WASHER". The FDA issued a decision of Substantially Equivalent on January 14, 1985. 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
- January 14, 1985
- Date Received
- October 22, 1984
- 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