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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 K132080
Device Name SNAP WOUND CARE SYSTEM
Applicant
Spiracur, Inc.
755 N. Mathilda Ave.
Sunnyvale,  CA  94085
Applicant Contact SARAH L CANIO
Correspondent
Spiracur, Inc.
755 N. Mathilda Ave.
Sunnyvale,  CA  94085
Correspondent Contact SARAH L CANIO
Regulation Number878.4683
Classification Product Code
OKO  
Date Received07/05/2013
Decision Date 03/12/2014
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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