510(k) K041704
K041704 is an FDA 510(k) premarket notification submitted by Newmedical Technology, Inc. for the device "NEWGEL AND NEWGEL PLUS E". The FDA issued a decision of Substantially Equivalent on Oct 17, 2005. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Newmedical Technology, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2005
- Date Received
- Jun 23, 2004
- 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
- 510(k) Exempt