510(k) K954736
K954736 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "ACCESS (POWERCLAVE)". The FDA issued a decision of Substantially Equivalent on August 15, 1996. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1996
- Date Received
- October 16, 1995
- 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