510(k) K173318
K173318 is an FDA 510(k) premarket notification submitted by 3M Deutschland GmbH for the device "Rapid HB, Rapid LB, Rapid MB". The FDA issued a decision of Substantially Equivalent on October 31, 2017. 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
- October 31, 2017
- Date Received
- October 20, 2017
- 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