510(k) K040517
K040517 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "TENDERWET ACTIVE". The FDA issued a decision of Substantially Equivalent on March 25, 2004. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2004
- Date Received
- February 27, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type