510(k) K043201
K043201 is an FDA 510(k) premarket notification submitted by Jensen Industries, Inc. for the device "WILLI GELLER CREATION ZI PORCELAIN". The FDA issued a decision of Substantially Equivalent on Jan 11, 2005. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Jensen Industries, Inc. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2005
- Date Received
- Nov 18, 2004
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type
- 510(k)