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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name speculum, vaginal, nonmetal
510(k) Number K022948
Device Name VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
Applicant
MEDICAL ACTION INDUSTRIES, INC.
2 SUMMIRT DR.
ARDEN,  NC  28704
Applicant Contact SHARON SUESS GRAHAM
Correspondent
MEDICAL ACTION INDUSTRIES, INC.
2 SUMMIRT DR.
ARDEN,  NC  28704
Correspondent Contact SHARON SUESS GRAHAM
Regulation Number884.4530
Classification Product Code
HIB  
Date Received09/05/2002
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
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