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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 K161658
Device Name Anexa Wound Flush, Sterile Water & Sterile Normal Saline
Applicant
Anexa Biomedical, Inc.
40423 Air Time Ave.
Zephyrhills,  FL  33542
Applicant Contact LENNY BUDLOO
Correspondent
Smith Assoicates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Classification Product Code
FRO  
Date Received06/16/2016
Decision Date 09/14/2016
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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