510(k) K925608
K925608 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT". The FDA issued a decision of Substantially Equivalent - Kit on Jun 16, 1993. The device falls under product code MFY (Endothelial Cell Harvesting Kit), a Class II device regulated under 21 CFR 870.4075. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Jun 16, 1993
- Date Received
- Nov 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Endothelial Cell Harvesting Kit
- Device Class
- Class II
- Regulation Number
- 870.4075
- Review Panel
- CV
- Submission Type
- Enforcement Discretion
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.