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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 K161311
Device Name USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
Applicant
Strukmyer Medical, LLC
1801 Big Town
Suite 100
Mesquite,  TX  75149
Applicant Contact ROBERT DELK
Correspondent
Richard Hamer Associates, LLC
705 Spring Lakes Blvd.
Bradenton,  FL  34210
Correspondent Contact RICHARD HAMER
Classification Product Code
FRO  
Date Received05/10/2016
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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