510(k) K030774
K030774 is an FDA 510(k) premarket notification submitted by Southwest Technologies, Inc. for the device "STIMULEN COLLAGEN". The FDA issued a decision of Substantially Equivalent on August 9, 2004. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Southwest Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2004
- Date Received
- March 11, 2003
- 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