510(k) K761015
K761015 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "MARKET CASTLE UNISPHERE". The FDA issued a decision of Substantially Equivalent on January 21, 1977. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Castle Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1977
- Date Received
- November 9, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type