510(k) K051256
K051256 is an FDA 510(k) premarket notification submitted by Noble Fiber Technologies, Inc. for the device "SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC". The FDA issued a decision of Substantially Equivalent on July 21, 2005. The device falls under product code ISH (Component, External, Limb, Ankle/Foot), a Class I device regulated under 21 CFR 890.3420. Noble Fiber Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2005
- Date Received
- May 16, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, External, Limb, Ankle/Foot
- Device Class
- Class I
- Regulation Number
- 890.3420
- Review Panel
- PM
- Submission Type