510(k) K984641
K984641 is an FDA 510(k) premarket notification submitted by Schoelly Fiberoptic GmbH for the device "FLEXISCOPE OPTOMODUL". The FDA issued a decision of Substantially Equivalent on March 29, 1999. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Schoelly Fiberoptic GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1999
- Date Received
- December 31, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type