510(k) K112872
K112872 is an FDA 510(k) premarket notification submitted by Scican , Ltd. for the device "STATIM 2000 G4 CASSETTE". The FDA issued a decision of Substantially Equivalent on July 10, 2012. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Scican , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2012
- Date Received
- September 30, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type