510(k) K823457
K823457 is an FDA 510(k) premarket notification submitted by Interdent, Inc. for the device "NON-PRESSURE AUTOCLAVE FOR STERILIZATION". The FDA issued a decision of Substantially Equivalent on February 23, 1983. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Interdent, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1983
- Date Received
- November 18, 1982
- 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