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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 K951480
Device Name MIST TROCARS
Applicant
MIST, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Applicant Contact CAROILANN KOTULA
Correspondent
MIST, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Correspondent Contact CAROILANN KOTULA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/30/1995
Decision Date 05/03/1995
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
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