510(k) K024160
K024160 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "NEOSPORIN SCAR SOLUTION". The FDA issued a decision of Substantially Equivalent on March 17, 2003. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2003
- Date Received
- December 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elastomer, Silicone, For Scar Management
- Device Class
- Class I
- Regulation Number
- 878.4025
- Review Panel
- SU
- Submission Type