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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 K980962
Device Name BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
Applicant
Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact KENNETH B HERLAND
Correspondent
Brennen Medical, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact KENNETH B HERLAND
Classification Product Code
MGQ  
Date Received03/16/1998
Decision Date 07/29/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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