510(k) K914701
K914701 is an FDA 510(k) premarket notification submitted by Degania Silicone , Ltd. for the device "SIL-K". The FDA issued a decision of Substantially Equivalent on January 31, 1992. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Degania Silicone , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1992
- Date Received
- October 18, 1991
- 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