510(k) K002315
K002315 is an FDA 510(k) premarket notification submitted by Wisebands , Ltd. for the device "WISEBANDS SKIN CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code MKY (System, Skin Closure), a Class I device regulated under 21 CFR 878.4320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2001
- Date Received
- July 31, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Skin Closure
- Device Class
- Class I
- Regulation Number
- 878.4320
- Review Panel
- SU
- Submission Type