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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, Hydrogel W/Drug And/Or Biologic
510(k) Number K000519
Device Name GLUCANPRO
Applicant
Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact PHIL LAWIN
Correspondent
Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact PHIL LAWIN
Classification Product Code
MGQ  
Date Received02/16/2000
Decision Date 05/01/2000
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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