510(k) K011026
K011026 is an FDA 510(k) premarket notification submitted by Organogenesis, Inc. for the device "FORTADERM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Jun 13, 2001. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Organogenesis, Inc. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 13, 2001
- Date Received
- Apr 4, 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
- Review Panel
- SU
- Submission Type
- 510(k)