510(k) K090670
K090670 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER". The FDA issued a decision of Substantially Equivalent on July 7, 2009. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Midmark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2009
- Date Received
- March 13, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type