510(k) K014068
K014068 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2002
- Date Received
- December 10, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type