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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
Predetermined Change
Control Plan Authorized		 No
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