SINGHMED ROOLIP MANIPULATOR


Device Classification Name

culdoscope (and accessories)

510(k) Number K110819
Device Name SINGHMED ROOLIP MANIPULATOR
Applicant
J.SINGH INSTRUMENTS
611 west 5th street
3rd floor
austin, 
TX 
78701

Applicant Contact caroline tontini
Correspondent
J.SINGH INSTRUMENTS
611 west 5th street
3rd floor
austin, 
TX 
78701

Correspodent Contact caroline tontini
Regulation Number 884.1640
Classification Product Code
HEW  
Subsequent Product Code
LKF  
Date Received 03/23/2011
Decision Date 10/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No