510(k) K992744
K992744 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MIDMARK M4*9 EASYCLAVE STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on January 10, 2000. 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
- January 10, 2000
- Date Received
- August 16, 1999
- 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