510(k) K014129
K014129 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Ltd. for the device "PROMOGRAN MATRIX WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 14, 2002. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Johnson & Johnson Medical, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2002
- Date Received
- December 17, 2001
- 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