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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 K110121
Device Name WEXLER ENDOSCOPE ACCESSORIES
Applicant
Microsurgical Laboratories,Inc.Dba Wexler Surgical
540 College St.
Bellaire,  TX  77401
Applicant Contact LISA S JONES
Correspondent
Microsurgical Laboratories,Inc.Dba Wexler Surgical
540 College St.
Bellaire,  TX  77401
Correspondent Contact LISA S JONES
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/18/2011
Decision Date 05/10/2011
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
Predetermined Change
Control Plan Authorized		 No
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