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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 K002896
Device Name ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
Applicant
The Westaim Corp.
1 Hampton Rd., #302
Exeter,  NH  03833
Applicant Contact STEVEN CHARTIER
Correspondent
The Westaim Corp.
1 Hampton Rd., #302
Exeter,  NH  03833
Correspondent Contact STEVEN CHARTIER
Classification Product Code
FRO  
Date Received09/18/2000
Decision Date 02/21/2001
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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