510(k) K061615
K061615 is an FDA 510(k) premarket notification submitted by Milliken Chemical for the device "INTERDRY TEXTILE WITH SILVER". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Milliken Chemical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- June 9, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fiber, Medical, Absorbent
- Device Class
- Class I
- Regulation Number
- 880.5300
- Review Panel
- HO
- Submission Type