510(k) K021064
K021064 is an FDA 510(k) premarket notification submitted by Scican for the device "QUANTIM 16 AUTOCLAVE". The FDA issued a decision of Substantially Equivalent on August 8, 2002. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Scican has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2002
- Date Received
- April 2, 2002
- Clearance Type
- Traditional
- 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