510(k) K981713

CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 by Smith & Nephew, Inc. — Product Code MGP

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