510(k) K003134
K003134 is an FDA 510(k) premarket notification submitted by Adri/Technam for the device "FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on December 22, 2000. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Adri/Technam has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2000
- Date Received
- October 6, 2000
- 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