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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 K924284
Device Name MICROSURGE DIRECTOR ARTICULATING INSTRUMENTS
Applicant
Micromec Surgical, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact TOBY JOHNSTON
Correspondent
Micromec Surgical, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact TOBY JOHNSTON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/25/1992
Decision Date 02/10/1993
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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