GYN DISPOSABLES TENACULUM 356T


Device Classification Name

tenaculum, uterine

510(k) Number K073182
Device Name GYN DISPOSABLES TENACULUM 356T
Applicant
GYN-DISPOSABLES, INC.
2671 appling road
memphis, 
TN 
38133 -5001

Applicant Contact james k patterson
Regulation Number 884.4530
Classification Product Code
HDC  
Date Received 11/13/2007
Decision Date 11/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls