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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Cleaner, Ultrasound
510(k) Number K162721
Device Name Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
Applicant
Alliqua Biomedical, Inc.
11495 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact KATHY SIMPSON
Correspondent
Alliqua Biomedical, Inc.
11495 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact KATHY SIMPSON
Regulation Number878.4410
Classification Product Code
NRB  
Date Received09/29/2016
Decision Date 12/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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