DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM


Device Classification Name

speculum, vaginal, nonmetal

510(k) Number K072762
Device Name DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
Applicant
DEPALT INC.
5013 stonewick court
plano, 
TX 
75093

Applicant Contact rajeev patel
Correspondent
DEPALT INC.
5013 stonewick court
plano, 
TX 
75093

Correspodent Contact rajeev patel
Regulation Number 884.4530
Classification Product Code
HIB  
Date Received 09/28/2007
Decision Date 01/22/2008
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