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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 K992221
Device Name ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
Applicant
Westaim Biomedical, Inc.
One Hampton Rd. Suite 302
Exeter,  NH  03833
Applicant Contact SALLY L MAHER
Correspondent
Westaim Biomedical, Inc.
One Hampton Rd. Suite 302
Exeter,  NH  03833
Correspondent Contact SALLY L MAHER
Classification Product Code
FRO  
Date Received07/01/1999
Decision Date 06/07/2000
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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