510(k) K990189
K990189 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on April 19, 1999. 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
- April 19, 1999
- Date Received
- January 20, 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