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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, Drug
510(k) Number K001519
Device Name ACTICOAT 7 DRESSING
Applicant
Westaim Biomedical, Inc.
One Hampton Rd. Suite 302
Exeter,  NH  03833
Applicant Contact Steve Chartier
Correspondent
Westaim Biomedical, Inc.
One Hampton Rd. Suite 302
Exeter,  NH  03833
Correspondent Contact Steve Chartier
Classification Product Code
FRO  
Date Received05/16/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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