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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K981713
Device Name CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
Applicant
Smith & Nephew, Inc.
11775 Starkey Rd.
Largo,  FL  33773
Applicant Contact JIM G IRVIN
Correspondent
Smith & Nephew, Inc.
11775 Starkey Rd.
Largo,  FL  33773
Correspondent Contact JIM G IRVIN
Classification Product Code
MGP  
Date Received05/15/1998
Decision Date 07/31/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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