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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Non-Powered Suction Apparatus
510(k) Number K151710
Device Name SNaP Wound Care System
Applicant
Spiracur, Inc.
1180 Bordeaux Dr.
Sunnyvale,  CA  94089
Applicant Contact LAWRENCE HU
Correspondent
Experien Group, LLC
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact RONALD S. WARREN
Regulation Number878.4683
Classification Product Code
OKO  
Date Received06/24/2015
Decision Date 11/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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