510(k) K131404
K131404 is an FDA 510(k) premarket notification submitted by 3M Deutschland GmbH for the device "FLASH AR PENTA / FLASH AR PENTA QUICK". The FDA issued a decision of Substantially Equivalent on May 30, 2013. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. 3M Deutschland GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2013
- Date Received
- May 15, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type