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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrode, Electrosurgical
510(k) Number K952323
Device Name MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
Applicant
MIST, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
MIST, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number878.4400
Classification Product Code
JOS  
Date Received05/18/1995
Decision Date 06/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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