510(k) K981713
K981713 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0". The FDA issued a decision of Substantially Equivalent on July 31, 1998. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1998
- Date Received
- May 15, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound And Burn, Occlusive
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type