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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 K020726
Device Name DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
Applicant
Dukal Corp.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact PATRICK J LAMB
Correspondent
Dukal Corp.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact PATRICK J LAMB
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/06/2002
Decision Date 05/15/2002
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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