REALHAND HIGH DEXTERITY INSTRUMENTS


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

Correspodent Contact david w schlerf
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 09/25/2007
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