MEDLINE DISPOSABLE VAGINAL SPECULUM


Device Classification Name

speculum, vaginal, nonmetal

510(k) Number K072942
Device Name MEDLINE DISPOSABLE VAGINAL SPECULUM
Applicant
MEDLINE INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Applicant Contact matt clausen
Correspondent
MEDLINE INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Correspodent Contact matt clausen
Regulation Number 884.4530
Classification Product Code
HIB  
Date Received 10/17/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No