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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 K002078
Device Name BETA GLUCAN GEL (MACROPRO GEL)
Applicant
Brennen Medical, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Applicant Contact PHILLIP LAWIN
Correspondent
Brennen Medical, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Correspondent Contact PHILLIP LAWIN
Classification Product Code
MGQ  
Date Received07/10/2000
Decision Date 10/02/2000
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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