510(k) K891589
K891589 is an FDA 510(k) premarket notification submitted by Semantodontics, Inc. for the device "3MM DISPOSABLE SPECULA". The FDA issued a decision of Substantially Equivalent on April 18, 1989. The device falls under product code FXG (Specula Accessories), a Class I device regulated under 21 CFR 878.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1989
- Date Received
- March 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Specula Accessories
- Device Class
- Class I
- Regulation Number
- 878.1800
- Review Panel
- SU
- Submission Type