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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 K940241
Device Name ACUFEX VIDEO SYSTEM
Applicant
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact FREDERICK TOBIA
Correspondent
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact FREDERICK TOBIA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/19/1994
Decision Date 04/12/1994
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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