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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 K945474
Device Name SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER
Applicant
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Applicant Contact KENNETH R BLAKE
Correspondent
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Correspondent Contact KENNETH R BLAKE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/08/1994
Decision Date 12/05/1994
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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