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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 K112666
Device Name SALINE WOUND WASH
Applicant
Nanoplas, Inc.
2140 Touhy Ave.
Elk Grove Village,  IL  60007
Applicant Contact RYAN LYTLE
Correspondent
Nanoplas, Inc.
2140 Touhy Ave.
Elk Grove Village,  IL  60007
Correspondent Contact RYAN LYTLE
Classification Product Code
FRO  
Date Received09/13/2011
Decision Date 04/20/2012
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
Recalls CDRH Recalls
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