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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 K072715
Device Name REALHAND HIGH DEXTERITY INSTRUMENTS
Applicant
NOVARE SURGICAL SYSTEMS, INC.
1070 CONCORD AVE., SUITE 230
CONCORD,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
NOVARE SURGICAL SYSTEMS, INC.
1070 CONCORD AVE., SUITE 230
CONCORD,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/25/2007
Decision Date 10/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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