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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 K172486
Device Name Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
Applicant
Anexa Biomedical, Inc.
40423 Air Time Ave.
Zephyrhills,  FL  33542
Applicant Contact Lenny Budloo
Correspondent
Anexa Biomedical, Inc.
40423 Air Time Ave.
Zephyrhills,  FL  33542
Correspondent Contact Shelly Budloo
Classification Product Code
FRO  
Date Received08/17/2017
Decision Date 09/21/2017
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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