510(k) K924380
K924380 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE". The FDA issued a decision of Substantially Equivalent on February 16, 1994. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1994
- Date Received
- August 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Chemical
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type