510(k) K134008
K134008 is an FDA 510(k) premarket notification submitted by Meta Biomed, Inc. for the device "MD-FLEX HEAVY BODY". The FDA issued a decision of Substantially Equivalent on Apr 9, 2014. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Meta Biomed, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 9, 2014
- Date Received
- Dec 30, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
- 510(k)