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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K152538
Device Name JRP Wound Spreader
Applicant
J.R. PARKER, LLC
1665 WARPATH ROAD
WEST CHESTER,  PA  19382
Applicant Contact J RICHARD PARKER
Correspondent
J.R. PARKER, LLC
1665 Warpath Road
West Chester,  PA  19382 -1745
Correspondent Contact J. Richard Parker
Regulation Number878.4800
Classification Product Code
GAD  
Date Received09/04/2015
Decision Date 04/13/2016
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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