510(k) K220736
K220736 is an FDA 510(k) premarket notification submitted by Consolidated Machine Corp. for the device "Consolidated HC Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on Aug 1, 2022. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Consolidated Machine Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 2022
- Date Received
- Mar 14, 2022
- Clearance Type
- Abbreviated
- 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
- 510(k)