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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 K931275
Device Name MIST MICROSURGICAL MONOPOLAR FORCEPS
Applicant
MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC.
CAROLANN KATULA-COOK
55 NORTHERN BLVD., SUITE 301
GREAT NECK,  NY  11021
Applicant Contact C/O M.D.I.
Correspondent
MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC.
CAROLANN KATULA-COOK
55 NORTHERN BLVD., SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact C/O M.D.I.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/08/1993
Decision Date 08/05/1993
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
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