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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 K083355
Device Name WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
Applicant
Blairex Laboratories, Inc.
1600 Brian Dr.
Columbus,  IN  47201
Applicant Contact CAREY BOTTOM
Correspondent
Blairex Laboratories, Inc.
1600 Brian Dr.
Columbus,  IN  47201
Correspondent Contact CAREY BOTTOM
Classification Product Code
FRO  
Date Received11/13/2008
Decision Date 12/29/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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