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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K150549
Device Name Reactor(TM) Trocar and Sleeve
Applicant
Sharp Medical Prducts, LLC
7694 E. Rose Garden Lane
Scottsdale,  AZ  85255
Applicant Contact Chris Salvino
Correspondent
McFarlane Medical, Inc.
2571 Kaneville Ct
Geneva,  IL  60134
Correspondent Contact Melanie Cox
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/03/2015
Decision Date 06/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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