510(k) K102946
K102946 is an FDA 510(k) premarket notification submitted by Coreleader Biotech Co., Ltd. for the device "CORELEADER COLLA-PAD MODEL CS 03030". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Coreleader Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2011
- Date Received
- October 4, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type