VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L


Device Classification Name

speculum, vaginal, nonmetal

510(k) Number K022948
Device Name VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
Original Applicant
MEDICAL ACTION INDUSTRIES, INC.
2 summirt dr.
arden, 
NC 
28704

Original Contact sharon suess graham
Regulation Number 884.4530
Classification Product Code
HIB  
Date Received 09/05/2002
Decision Date 11/04/2002
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