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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound retraction and protection system
510(k) Number K172132
Device Name CleanCision Wound Retraction and Protection System
Applicant
Prescient Surgical, Inc.
1585 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact Lisa Claude
Correspondent
Prescient Surgical, Inc.
1585 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact Lisa Claude
Regulation Number878.4371
Classification Product Code
PQI  
Date Received07/14/2017
Decision Date 10/25/2017
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
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