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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 K954072
Device Name MICROSURGE PUNCTURE CLOSE DEVICE
Applicant
MICROSURGE, INC.
150 A ST.
NEEDHAM,  MA  02194
Applicant Contact RICHARD LARIVERE
Correspondent
MICROSURGE, INC.
150 A ST.
NEEDHAM,  MA  02194
Correspondent Contact RICHARD LARIVERE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/30/1995
Decision Date 10/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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