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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 K111845
Device Name THE ESPINER SAC OR E SAC
Applicant
ESPINER MEDICAL LIMITED
116 ALMOND ROAD, CUMBERNAULD
GLASGOW,  GB G673LW
Applicant Contact EDWIN LINDSAY
Correspondent
ESPINER MEDICAL LIMITED
116 ALMOND ROAD, CUMBERNAULD
GLASGOW,  GB G673LW
Correspondent Contact EDWIN LINDSAY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/29/2011
Decision Date 09/26/2011
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
Recalls CDRH Recalls
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