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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 K951646
Device Name 3DSEE
Applicant
Intl. Telepresence Corp.
One Financial Center
Boston,  MA  02111
Applicant Contact CAROLYN S LANGER
Correspondent
Intl. Telepresence Corp.
One Financial Center
Boston,  MA  02111
Correspondent Contact CAROLYN S LANGER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/10/1995
Decision Date 10/04/1995
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
Predetermined Change
Control Plan Authorized		 No
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