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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 K070964
Device Name KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Applicant Contact CHRIS HORACEK
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Correspondent Contact CHRIS HORACEK
Regulation Number884.4530
Classification Product Code
HIB  
Date Received04/05/2007
Decision Date 05/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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